Base: $252,000 to $269,000; bonus: eligible for an...
**
15+ years industry experience
8+ years gcp management sponsor
Risk-based audit program design
**
Alkermes is seeking a Senior Director of Clinical Quality Assurance to lead and oversee compliance for global clinical trials, focusing on Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP). The ideal candidate will have significant experience in clinical quality assurance, personnel management, and a strong ability to navigate regulatory environments.
**
Job Summary
This role provides strategic leadership for Alkermes GLP/GCP/GVP quality programs to ensure compliance across global clinical trials.
The successful candidate will lead the development of risk-based audit programs and manage Health Authority inspections including mock BIMO interviews.
Alkermes offers a competitive benefits package and has been recognized as a Great Place to Work in the U.S. and by Fortune Magazine.
Matching Summary
Match Score: 75
**
Alkermes is seeking a Senior Director of Clinical Quality Assurance to lead and oversee compliance for global clinical trials, focusing on Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP). The ideal candidate will have significant experience in clinical quality assurance, personnel management, and a strong ability to navigate regulatory environments.
**
Salary
Base: $252,000 to $269,000; Bonus: Eligible for annual performance pay bonus; Benefits: Competitive benefits package offered
Skills & Requirements
Must-have
15+ years industry experience
8+ years GCP management sponsor
Risk-based audit program design
Health authority inspection hosting
ICH E6(R2/R3) and ICH E8(R1)
Matrixed team collaboration
Nice-to-have
High throughput clinical sponsor activity
NDA/BIMO milestone support
Continuous improvement culture
Advanced regulatory anticipation
Cross-functional strategic influence
Key Requirements
Bachelor's degree in life sciences or related field
15+ years experience in high throughput clinical sponsor activity
8+ years experience in GCP management with a Sponsor company
Experience hosting FDA, EMA, MHRA, and Asia jurisdiction inspections
Proven people management across multiple sites and locations