Senior Director, Clinical QA & Inspection Readiness

Alkermes; Boston (MA); On-site; USD 252,000 - 269,000; Full time

Benefits offered by this job

Annual performance pay bonus

Competitive benefits package

Job summary

Alkermes is seeking a Clinical Quality Assurance Senior Leader in Boston, MA. This role involves strategic leadership and operational oversight of GCP/GLP/GVP quality programs to ensure compliance in clinical trials. Candidates must have 15+ years of experience in clinical sponsor activity and 8+ years in GCP management. The position offers a salary range of $252,000-$269,000 annually plus performance bonuses and a competitive benefits package.

Qualifications

• 15+ years’ experience in clinical sponsor activity with 8+ years in GCP management.
• Strong understanding of GCP, GLP, and GVP regulations applicable across various jurisdictions.
• Experience in hosting regulatory inspections (FDA, EMA, etc.).

Responsibilities

• Provide strategic leadership for Alkermes quality programs in clinical trials.
• Manage risk-based quality systems and ensure inspection readiness.
• Lead the design of GCP audit programs and inspection initiatives.

Skills

GCP management

Personnel management

Interpersonal skills

Problem solving

Communication skills

Education

Bachelor's degree in life sciences, pharmacy, nursing, or a related field

Job description

Alkermes is seeking a Clinical Quality Assurance Senior Leader in Boston, MA. This role involves strategic leadership and operational oversight of GCP/GLP/GVP quality programs to ensure compliance in clinical trials. Candidates must have 15+ years of experience in clinical sponsor activity and 8+ years in GCP management. The position offers a salary range of $252,000-$269,000 annually plus performance bonuses and a competitive benefits package.