Senior Director, Clinical Quality Assurance

Role: Senior Leader in Clinical Quality Assurance overseeing Alkermes' GLP/GCP/GVP compliance for global clinical trials. Responsibilities: develop strategic vision, lead risk assessments, ensure inspection readiness, manage audits and inspections, and foster cross-functional compliance collaboration. Manage a team supporting quality programs, policies, and continuous improvement initiatives across multiple jurisdictions. Qualifications: Bachelor's in life sciences or related field; 15+ years industry experience including 8+ years in GCP management, with expertise in GLP, GCP, GVP, and regulatory inspection processes. Preferred skills include personnel management, strong communication, influencing abilities, and industry-standard technological proficiency. High-value specifics: focus on clinical development, regulatory inspection readiness, GxP compliance, and risk management across international jurisdictions. Work setup: Hybrid in Waltham, MA, with at least 3 days onsite, flexible working model.