Senior Director, Clinical Quality Assurance

Alkermes; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Alkermes is seeking a Clinical Quality Assurance Senior Leader to provide strategic leadership and operational oversight of GLP/GCP/GVP quality programs across global clinical trials. This role ensures readiness for inspections, supports NDA/BIMO milestones, and collaborates across departments to advance development programs.

You will build high-performing teams, influence in a matrixed environment, and anticipate evolving regulatory expectations to maintain compliant quality systems.

Qualifications

• Strategic leadership of GLP/GCP/GVP quality programs across global clinical trials.
• Ability to build high-performing teams and influence in a matrixed environment.
• Coordinate readiness for Health Authority inspections and NDA/BIMO milestones.

Responsibilities

• Develop risk-based audit programs for GLP/GCP/GVP.
• Direct inspection readiness and hosting of Health Authority inspections.

Job description

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 teamresponsible 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.