Senior Director, Clinical QA: Inspection-Ready & Risk-Based

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

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.