Daiichi Sankyo Company,limited jobs

Expert QA Operations CSV (m/w/d) - IT/OT-Systems Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Purpose of the function Ab sofort suchen wir für unseren Standort in Pfaffenhofen an der Ilm eine engagierte Person, die unser QA Operations Team bei der Sicherstellung der Einhaltung regulatorischer Anforderungen, interner Anweisungen sowie der Anforderungen an Operational Technology (OT) und computergestützte Systeme unterstützt und zusätzlich bei der Qualifizierung und Validierung der zugehörigen Anlagen mitwirkt. Roles and Responsibilities Verantwortlich für die QA Oversight der Operational Technology (OT) zugehörigen Infrastruktur und Software QA Oversight in der Validierung von Software und computergestützten Systemen gemäß aktueller Richtlinien (EU GMP Annex 11 bzw. Annex 15, 21 CFR Part 11, GAMP5) Prüfung und Freigabe von Validierungs- und Qualifizierungsdokumenten wie URS, Risikoanalysen, Validierungs- bzw. Qualifizierungsplänen/-berichten, Testdokumenten, Traceability-Matrizen im Bereich OT und computergestützte S

Head of Global Biostatistics Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary This role, reporting to the Head of Global Biostatistics & Data Management, sets the vision and strategy for the statistical function within R&D. Creates a strong statistical practice, motivating and inspiring people and the department to grow and learn continuously. Reviews and provides strategic inputs to the entire portfolio of DS from pre-clinical through life cycle management. Accountable for the quality and timeline for all statistical deliverables. Promotes, oversees, and be accountable for statistical innovation, standards and processes in drug research and development. High-level negotiation and oversight of external vendors in vendor/sponsor partnership. Collaboration with other functions and partners in supporting preclinical and clinical activities. Accountable for the management, performance, and development, both technical and career, of direct reports, and mentors or acts as functional leadership

Assistant General Counsel Commercial Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary Work in an exciting and challenging legal environment by independently providing innovative and strategic legal support and solutions as a brand attorney and the primary legal advisor for the commercial business and operations supporting U.S. approved (or to be approved) oncology products and to specific assigned business functions in the Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs, Sales, Marketing, etc.) including, but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is required. Provides appropriate counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor in order to foster their professional growth and development as well as their achievement of Company and/or departmental expectations and goals as identified by

Director, Regulatory Affairs Advertising and Promotion Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior strategic and tactical regulatory leadership for U.S. promotional and selected non-promotional communications across assigned products, therapeutic areas, and key business initiatives within the Daiichi Sankyo portfolio, including alliance assets. Reporting to the Head of RAAP, this role serves as a senior regulatory advertising and promotion subject matter expert and is accountable for guiding compliant, effective communications in alignment with FDA regulations, guidance, enforcement trends, approved labeling, internal standards, and business objectives. The Director is responsible for leading regulatory strategy and decision-making for complex, high-risk, high-visibility, or precedent-setting advertising and promotion matters. This role serves as a senior advisor to cross-functional stakeholders, plays a significant role in labe

Director, Early Phase Biostatistics (m/f/d) Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary Position leads multiple early phase compounds or complex studies contributing to clinical development plan, and responsible for statistical design, analysis and interpretation of results independently with minimal supervision. This position provides strategic inputs to entire drug development plans with minimal supervision and regulatory responses and other documents with minimal supervision. This position interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians. Additionally, this position works under minimal supervision to solve complex project problems. This position utilizes innovative trial designs and modeling to optimize the statistical handling in the projects, in collaboration with statistical innovation group, precision medicine biostat group, and real-world data (RWD) group. This position collaborates with cross fu

Director, Early Phase Biostatistics Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary Position leads multiple early phase compounds or complex studies contributing to clinical development plan, and responsible for statistical design, analysis and interpretation of results independently with minimal supervision. This position provides strategic inputs to entire drug development plans with minimal supervision and regulatory responses and other documents with minimal supervision. This position interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians. Additionally, this position works under minimal supervision to solve complex project problems. This position utilizes innovative trial designs and modeling to optimize the statistical handling in the projects, in collaboration with statistical innovation group, precision medicine biostat group, and real-world data (RWD) group. This position collaborates with cross fu

Senior Director, Clinical Safety MD Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Sr. Director, Clinical Safety, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Development Sankyo's development compounds through the Safety Management Team framework. This individual will use strong leadership and communication skills to successfully coordinate resources and ensure effective collaboration across development functions and sites. The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization). Job Description Responsibilities Dependin

Associate Director PV Quality, Americas Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary Participate in the implementation of the quality strategy closely aligned with the business strategy within the CSPV function. Provide strategic and proactive QA Leadership and support development Project Teams and CSPV with adequate quality and compliance guidance in close alignment with the Head of Global PV QA Americas. Including, daily consultation to CSPV unit to harmonize end to end "proactive quality". Advise development teams in quality and compliance decision making to drive sustainable quality and compliance excellence. Provide quality and compliance guidance for process deviations and implementation of corrective and preventive actions, including enhanced involvement on Root Cause Analysis (RCA); monitor their status and timely closure. Support risk management activities, including trend analysis KQIs (e.g. Audits, Inspections, QIs including late ICSR submission of reports, and their CAPAs, etc.) from

Scientist (m/f/d) GMP ADC Manufacturing Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. For our development and production site in Pfaffenhofen an der Ilm we are seeking highly qualified candidates to fill the position: Scientist (m/f/d) GMP Manufacturing ADC The position: The Scientist GMP manufacturing ADC will be a key contributor to the establishment of a new drug substance production unit for Antibody-Drug Conjugates (ADC) at the site in Pfaffenhofen. Your primary role will be to support the establishment of the new production facility as expert from GMP perspective, including the generation of the required GMP documents. Once the facility is up and running, your task will be to contribute to all operations and maintenance in this GMP bioconjugation facility. You task will include to ensure performance of your tasks in compliance with the regulatory requirements and collaborating with other departments to support manufacturing with good quality. Roles and responsibilities: • Contribute to the planning of

Sr Analyst Engagement Monitoring Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary This position is primarily responsible for monitoring / auditing HCP (Health Care Provider) activities for all engagements pertaining to their travel and/or attendance at meetings, speaker programs, and conventions as well as single engagements in support of DSI (commercial and development organizations). This role is also responsible for monitoring and auditing all non-HCP meetings and activities according to DSI policies. The role will have primary responsibility within Corporate Programs & Events for ensuring DSI's compliance with all CIA related policies, state and federal regulations regarding payments to HCPs and reporting of such for the listed activities. Job Description Responsibilities HCP Engagement folders - Establish and manage the monthly HCP Engagement Folder audit process, to ensure information is documented and reported timely. Folder Audit includes: Review HCP Engagements that are considered cl

Senior Manager (m/w/d) Production Excellence & Operational Support Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Die Position: Verantwortlich fuer die Steuerung und Weiterentwicklung von Validierungs- und Qualifizierungsstrategien im Produktionsumfeld, die uebergreifende Unterstuetzung der Betriebsabteilungen sowie die Fuehrung komplexer, bereichsuebergreifender GMP-Themen und Projekte mit massgeblichem Einfluss auf Compliance, Inspektionsfaehigkeit und die nachhaltige Optimierung von Produktionsstandards. Angaben zur Tätigkeit: Selbstständige Planung, Steuerung und Verantwortung von komplexen Validierungsprojekten im Produktionsumfeld (Herstell- und Reinigungsprozesse sowie aseptische Produktionsverfahren) Gesamtverantwortung für Qualifizierungsstrategien (PQs) und deren Umsetzung Konzeptionelle Mitgestaltung von Anlagen, Technologien und Investitionen Selbstständige Vertretung der Produktion bei Produkttransfers im Rahmen von Site-Launch-Teams Verantwortung für die Bearbeitung komplexer Abweichungen inkl. systemischer Ursachenanalys

Oncology Territory Manager, Lung - Sioux Falls, SD Work Model Remote Field (Daiichi Sankyo US) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product, and its approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. Responsibilities Represents the assigned products to health care professionals in assigned sales territory. Achieves or exceeds sales objectives through promotion of the assigned product features and benefits to assigned customers. Develop and execute comprehensive business plans. Applying knowledge of the healthcare industry, trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmacy economics, payer reimbursement landscape, and patientflow/influence between academic institutions, hospitals, and community practices). Demonstrate understanding of curre

Oncology Territory Manager, Lung - Minneapolis Work Model Remote Field (Daiichi Sankyo US) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product, and its approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. Responsibilities Represents the assigned products to health care professionals in assigned sales territory. Achieves or exceeds sales objectives through promotion of the assigned product features and benefits to assigned customers. Develop and execute comprehensive business plans. Applying knowledge of the healthcare industry, trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmacy economics, payer reimbursement landscape, and patient flow/influence between academic institutions, hospitals, and community practices). Demonstrate understanding of curr

Oncology Territory Manager, Lung - Phoenix N Work Model Remote Field (Daiichi Sankyo US) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product, and its approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. Responsibilities Represents the assigned products to health care professionals in assigned sales territory. Achieves or exceeds sales objectives through promotion of the assigned product features and benefits to assigned customers. Develop and execute comprehensive business plans. Applying knowledge of the healthcare industry, trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmacy economics, payer reimbursement landscape, and patientflow/influence between academic institutions, hospitals, and community practices). Demonstrate understanding of curre

Oncology Territory Manager, Lung - Baltimore Work Model Remote Field (Daiichi Sankyo US) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product, and its approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. Responsibilities Represents the assigned products to health care professionals in assigned sales territory. Achieves or exceeds sales objectives through promotion of the assigned product features and benefits to assigned customers. Develop and execute comprehensive business plans. Applying knowledge of the healthcare industry, trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmacy economics, payer reimbursement landscape, and patient flow/influence between academic institutions, hospitals, and community practices). Demonstrate understanding of curr

Oncology Territory Manager, Lung - Miami Work Model Remote Field (Daiichi Sankyo US) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product, and its approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. Responsibilities Represents the assigned products to health care professionals in assigned sales territory. Achieves or exceeds sales objectives through promotion of the assigned product features and benefits to assigned customers. Develop and execute comprehensive business plans. Applying knowledge of the healthcare industry, trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmacy economics, payer reimbursement landscape, and patient flow/influence between academic institutions, hospitals, and community practices). Demonstrate understanding of curr

Mitarbeiter (m/w/d) für die Herstellung von sterilen Arzneimitteln Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Angaben zur Tätigkeit: Als Mitarbeiter (m/w/d) für die Herstellung unserer sterilen, biotechnologischen Arzneimittel sorgen Sie eigenständig für die Bedienung von vollautomatischen, computergestützten Ansatz-, Abfüll-, Gefriertrocknungs- und Verbördelungsanlagen mit Isolatortechnologie unter Reinraumbedingungen Vorbereitende Tätigkeiten, wie z.B. Einrichtung und Rüstung der Produktionsanlagen, Zusammenbau von Einwegkomponenten sowie Herstellung von Ansätzen gehören ebenso zu Ihrem Aufgabenpaket Wir vertrauen Ihnen die Reinigung und Sterilisation der Produktionsanlagen und Reinräume an, die Sie gemäß Arbeitsanweisung, Hygieneplan bzw. durch vollautomatische Programme durchführen Ihre Tätigkeit umfasst auch die Dokumentation der durchgeführten Tätigkeiten entsprechend der arzneimittelrechtlichen Vorgaben in elektronischen Herstellprotokollen sowie Logbüchern Wir binden Sie bei der kontinuierlichen Optimierung unserer Prozesse

Oncology Clinical Educator - AR/MS/AL Work Model Remote Field (Daiichi Sankyo US) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Oncology Clinical Educator role provides disease state, REMS, and product safety education and training to key healthcare providers within Oncology clinics, and health care providers (HCPs) in both the hospital and clinic/office setting. The individual will work within a specified region to enhance disease, REMS, and product safety knowledge, coordinate and provide staff training, and enhance proper administration. The Oncology Clinical Educator (OCE) role is a position that is field based and is comprised of nurses working under the general direction of the Regional Director of Clinical Nurse Managers. The OCE is responsible for educating HCPs/clinics with infusion and related education for prescribed DSI products. The OCE serves as the disease state and product safety expert for their assigned territories. The OCE serves as a resource to clinical leaders by identifying disease state, REMS, and product safe

Schichtleiter (m/w/d) für die Verpackung steriler Arzneimittel Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Angaben zur Tätigkeit: Sie sind verantwortlich für die Steuerung und Überwachung der operativen Prozesse und Ergebnisse des Schichtteams hinsichtlich einer termin-, mengen-, qualitätsgerechten und kostenoptimalen Produktion im Bereich Vial-Verpackung Sie vertreten das Schichtteam gegenüber Team- und Abteilungsleitung sowie gegenüber den anderen Schichtleitern Ihnen obliegt die fachliche und disziplinarische Personalführung (inkl. Personaleinsatzplanung und Mitarbeiterentwicklung) ihres Schichtteams Sie verantworten die Umsetzung der GMP-konformen Herstellung im Bereich Vial-Verpackung und unterstützen bei der Optimierung von Prozessen Sie führen selbstständig GMP- und Sicherheitsschulungen durch und unterstützen bei der Durchführung von Validierungs- und PQ-Läufen Sie erfassen festgelegte Schicht-Kennzahlen selbstständig und stellen diese in Regelterminen vor Sie erfassen Abweichungen und leisten fachliche Unterstützung bei

Senior Manager Medical Affairs QA (m/f/d) Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Purpose of the function LOCATION: Munich, Germany The Senior Manager, Medical Affairs QA provides leadership and strategic direction for assigned programs, ensuring the effective implementation of quality strategies and fostering a quality-driven culture within Medical Affairs. This role oversees strategic quality initiatives in close collaboration with Medical Affairs stakeholders and serves as the primary QA point of contact for all Medical Affairs programs. Reporting to the Head of Development and Medical Affairs QA, the Senior Manager is responsible for end-to-end quality oversight across interventional and non-interventional studies, investigator-initiated studies, and managed access or compassionate use programs. This includes ensuring compliance with GCP, GPV, data protection, and applicable local regulatory requirements throughout program planning and execution. In close alignment with Development Sciences QA teams

Specialist Accounting (m/f/d) Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. The Position: the role is a fixed-term role for 18 months Support all accounting activities in the defined regional scope in the GBS ESC to ensure the performance of accounting services in high quality as well as in a timely and fully compliant manner Support building up and stabilizing the new organizational set-up of the GBS ESC and the new end-to-end (E2E) processes in the defined regional scope of the GBS ESC Closely collaborate within the service line teams and support other GBS ESC service line teams as aligned with the responsible line manager to ensure that all interfaces are fully covered Roles and Responsibilities: Operate all accounting-related transactions in sub-ledgers and Cash Operations, especially related to Order-to-Cash (O2C), Procure-to-Pay (P2P), Bank Accounting, and Master Data considering relevant accounting and VAT regulations Timely and exhaustively post accruals and provisions; prepare and execute

Associate Director, Regulatory (RIM) Business Systems and Operations Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Associate Director, Business Systems & Operations Management is responsible for managing the operational, administrative, and tactical support of assigned business systems; as well as contributing to projects and initiatives that optimize the use of information technology to achieve departmental, divisional, and enterprise business objectives. The Associate Director, Business Systems & Operations Management will function at various times as a manager of one or more business systems, as a leader of sub-teams or workstreams within larger projects or programs, as a contributor within various systems-related working groups, and as a senior business analyst, as required. This role regularly collaborates with business leadership, business process owners, business analysts, R&D Excellence team members, and information technology leads and specialists. This role often involves the oversight of internal or contracted

Head of QC Laboratory (m/w/d) Bioanalytics Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Purpose of the function Ab sofort suchen wir für unseren Standort in Pfaffenhofen eine/n engagierte/n Head of QC Laboratory (m/w/d) Bioanalytics In dieser Position übernehmen Sie die fachliche und disziplinarische Leitung der Laborgruppe Bioanalytik innerhalb der pharmazeutischen Qualitätskontrolle. Sie stellen sicher, dass alle bioanalytischen Prüfungen den geltenden GMP‑Regelwerken, den Zulassungsunterlagen sowie dem aktuellen Stand von Wissenschaft und Technik entsprechen. Ein wichtiger Schwerpunkt liegt auf der robusten, regulatorisch konformen Gestaltung aller QC‑Prozesse im Bereich der ADC‑Analytik sowie in der kontinuierlichen Weiterentwicklung des Laborbereichs. Darüber hinaus verantworten Sie den sicheren, effizienten und termingerechten Ablauf aller analytischen Tätigkeiten Ihres Teams, vertreten den Bereich gegenüber internen und externen Partnern und tragen maßgeblich zur Vorbereitung und Durchführung von Inspek

Specialist (m/w/d) MAH QA Compliance Work Model Office Based Role (Daiichi Sankyo Europe) | Job Location (Country/Region) At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Purpose of the function Ab sofort suchen wir für unseren Standort in Pfaffenhofen oder München eine/n engagierte/n Specialist (m/w/d) MAH QA Compliance Angaben zur Tätigkeit: Als Specialist (m/w/d) MAH QA Compliance unterstützen Sie das Team bei allen Qualitätssicherungsaktivitäten des MAH QA Teams mit Fokus auf folgende Bereiche: Eigenverantwortliche Prozessierung von pharmazeutisch-technischen Reklamationen (PTCs), Fälschungsverdachtsfällen und Fällen im Bereich Serialisierung im internationalen Umfeld. Dazu gehören u.a.: Aufnahme (Prüfen auf Minimalkriterien, Loggen, Kommunizieren) und Abschlussmitteilung von PTCs, Fälschungsverdachtsfällen und Fällen im Bereich Serialisierung in Trackwise (eQMS) im Austausch mit internationalen, externen und internen Stakeholdern Koordination der eingehenden Reklamationsmuster nach vorgegebenen Richtlinien Nachverfolgung der Untersuchungen und der festgelegten CAPAs zur Einhaltung inter