Senior Director, Clinical Quality Assurance

Alkermes • Waltham, MA

9h

About The Position

This Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight of Alkermes GLP/GCP/GVP quality programs to ensure compliance across global clinical trials. This leader ensures the organization is ready for inspections, implements and manages risk-based quality systems, collaborates across departments to advance development programs, and supports the team for NDA/BIMO milestone achievements. This role requires an experienced Clinical QA Senior leader who can build high‑performing teams, influence in a matrixed environment, anticipate and respond to evolving regulatory expectations. Responsible for the Clinical Quality Assurance (CQA) unit within the Alkermes organization. The CQA unit consists principally of a team based out of Waltham supported by individuals across the sites and Contract Auditors on “an-as-required” basis. A member of the Alkermes Quality leadership team responsible for overall Quality culture and continuous improvement of Alkermes QMS and compliance, and leads the Alkermes strategy and GXP compliance on all matters concerning Quality in the areas of; Good Laboratory Practices (GLP), Good Clinical Practices (GCPs), and Good Pharmacovigilance Practices pre and post market (GVPs). Directs a team in the development of all applicable; risk-based audit programs, inspection readiness and hosting of Health Authority Inspections.

Requirements

• Experienced Clinical QA Senior leader
• Can build high‑performing teams
• Can influence in a matrixed environment
• Can anticipate and respond to evolving regulatory expectations

Responsibilities

• Provides strategic leadership and operational oversight of Alkermes GLP/GCP/GVP quality programs to ensure compliance across global clinical trials.
• Ensures the organization is ready for inspections.
• Implements and manages risk-based quality systems.
• Collaborates across departments to advance development programs.
• Supports the team for NDA/BIMO milestone achievements.
• Responsible for the Clinical Quality Assurance (CQA) unit within the Alkermes organization.
• Leads the Alkermes strategy and GXP compliance on all matters concerning Quality in the areas of; Good Laboratory Practices (GLP), Good Clinical Practices (GCPs), and Good Pharmacovigilance Practices pre and post market (GVPs).
• Directs a team in the development of all applicable; risk-based audit programs, inspection readiness and hosting of Health Authority Inspections.

Benefits

• Portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy
• Pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders
• Certified as a Great Place to Work in the U.S. (2024 and 2025)
• Named one of Massachusetts’ Top Places to Work by the Boston Globe
• Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier
• Best Place to Work in BioPharma by Fortune Magazine

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed