Associate Director, Clinical QA
Alkermes - Waltham, MA, United States
Posted Dec 8, 2025
Benefits
- Parental leave
- Not verified
- Non-birth-parent leave
- Not verified
- Family-building benefits
-
- Fertility benefits: Not verified
- Adoption assistance: Not verified
- Surrogacy assistance: Not verified
- Mental health support
- Not verified
- Relocation assistance
- Not verified
- Childcare support
- Not verified
- Learning budget
- Not verified
- Verification
- Not verified checked Jun 13, 2026
- Salary
- $167K-$182K From the posting source checked Jun 20, 2026
- 401(k) match
- Reported from DOL Form 5500 industry filing (not employer-specific)
Was this benefit information wrong? Tell us.
Market context
- U.S. role benchmark (BLS OEWS)
- $81,444 U.S. median for this role
- Projected growth (BLS Employment Projections)
- +6.9% - Faster than average
114% above the BLS role benchmark for healthcare aggregate.
Matched to SOC 29-1141 - Healthcare aggregate by role bucket.
Source: U.S. Bureau of Labor Statistics, OEWS, May 2024 and Employment Projections, 2024-2034.
Role
Schedule
- Shift type
- Not verified
- Weekend work
- Not verified
Company
Application
- Cover letter
- Not verified
- Assessment
- Not verified
- Deadline
- Not stated
Where they hire
State eligibility is not yet verified.
About this role
Associate Director, Clinical QA Waltham, MA, United States This position is an integral part of the CQA team and provides oversight for and participates in, auditing services in support of Alkermes Clinical Programs by conducting clinical site, vendor qualification, internal systems and document audits to ensure compliance with cGCPs. The CQA Manager supports the department initiatives by leading CQA projects and assists with management of department resources. This position must be able to quickly identify critical and high risk business and compliance issues and report immediately to CQA management and assist/lead investigations and/or corrections of such issues. In addition to a travel requirement of ~40%, this person will also need to be onsite and local to our Waltham, MA office 3x a week. This position will : Schedule, personally conduct and/or supervise Good Clinical Practice (GCP) audit services by an external vendor/consultant and/or internal resources (auditors) which will support Clinical Development activities including but not limited to: Audits of clinical vendors, clinical sites and clinical documents that will be submitted to regulatory authorities Audits of clinical drug safety activities internally and externally/ vendors Internal and external clinical development and drug safety systems Work with contract auditors and CQA management to develop study specific audit plans Review and assess internal and external audit reports to ensure they have met the audit plan and that recommendations and suggested Corrective Action Preventative Action Plans (CAPA) are adequate all to ensure compliance with Standard Operating Procedures (SOPs), Regulations, and Best Practices Oversee and/or Conduct
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Apply link verified; last checked Aug 3, 2026.
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