Manager, Clinical Quality Assurance

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

$135K-$149K not verified - source not recorded; timestamp not recorded

401(k) match

Reported from DOL Form 5500 industry filing (not employer-specific)

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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

74% 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.

Schedule

Shift type

Not verified

Weekend work

Not verified

Application

Cover letter

Not verified

Assessment

Not verified

Deadline

Not stated

Where they hire

State eligibility is not yet verified.

About this role

Manager, Clinical Quality Assurance Waltham, MA, United States The Manager 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 and deliverables. 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. This position reports to the Director of Clinical Quality Assurance and will be onsite in a hybrid compacity at our Waltham, MA office. Schedule, 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 other GCP related audits as indicated

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