Senior Director, Clinical Quality Assurance
Alkermes
August 13, 2026
Remote friendly (Greater Boston)
United States
Clinical Research and Development
Responsibilities
- Develop and execute a clinical QA strategic vision aligned to business/program objectives.
- Lead risk management assessments to ensure patient safety (during trials and post‑market).
- Set and manage goals, budgets, headcount plans, and performance metrics for Clinical QA.
- Anticipate regulatory changes and evolving GCP/GVP/GLP expectations.
- Serve as senior Clinical QA representative across program/sub/study teams.
- Ensure GCP/GVP/GLP compliance globally; apply CtQ principles (ICH E8(R1), ICH E6(R2/R3)).
- Oversee development/implementation/continuous improvement of clinical quality systems (policies, processes, SOPs, governance) and coordinate with GMP.
- Design and execute risk-based audit programs (internal, CRO, vendor, sites routine/for-cause).
- Evaluate audit findings; ensure timely CAPA development and closure.
- Lead GCP inspection readiness (mock BIMO interviews, preparedness plans, cross-functional training).
- Manage sponsor BIMO inspections and support CRO inspections.
- Partner cross-functionally to ensure operational compliance and review key documents (INDs, protocols, IBs, NDAs, submissions).
- Maintain a risk-based oversight strategy; support investigations (deviations, noncompliance, GCP violations) with root cause analysis and CAPA effectiveness.
- Lead/oversee GCP training and communicate compliance expectations.
- Lead, mentor, and develop Clinical QA personnel; select/manage qualified resources.
Qualifications
- Bachelor’s degree (life sciences, pharmacy, nursing, or related science field).
- Preferred: strong people management; deep understanding of GCP/GLP/GVP regulations and guidance across worldwide jurisdictions.
- Strong interpersonal, written/oral communication, influencing/collaboration; team player with compliance focus; highly motivated.
- 15+ years clinical sponsor QA experience; 8+ years in GCP management (sponsor company).
- Experience hosting inspections across multiple jurisdictions (e.g., FDA, Canada, EMA, MHRA, Asia).
- Experience managing people across sites/locations.
Compensation
- Annual base salary: $252,000–$269,000; eligible for annual performance pay bonus.
- Develop and execute a clinical QA strategic vision aligned to business/program objectives.
- Lead risk management assessments to ensure patient safety (during trials and post‑market).
- Set and manage goals, budgets, headcount plans, and performance metrics for Clinical QA.
- Anticipate regulatory changes and evolving GCP/GVP/GLP expectations.
- Serve as senior Clinical QA representative across program/sub/study teams.
- Ensure GCP/GVP/GLP compliance globally; apply CtQ principles (ICH E8(R1), ICH E6(R2/R3)).
- Oversee development/implementation/continuous improvement of clinical quality systems (policies, processes, SOPs, governance) and coordinate with GMP.
- Design and execute risk-based audit programs (internal, CRO, vendor, sites routine/for-cause).
- Evaluate audit findings; ensure timely CAPA development and closure.
- Lead GCP inspection readiness (mock BIMO interviews, preparedness plans, cross-functional training).
- Manage sponsor BIMO inspections and support CRO inspections.
- Partner cross-functionally to ensure operational compliance and review key documents (INDs, protocols, IBs, NDAs, submissions).
- Maintain a risk-based oversight strategy; support investigations (deviations, noncompliance, GCP violations) with root cause analysis and CAPA effectiveness.
- Lead/oversee GCP training and communicate compliance expectations.
- Lead, mentor, and develop Clinical QA personnel; select/manage qualified resources.
Qualifications
- Bachelor’s degree (life sciences, pharmacy, nursing, or related science field).
- Preferred: strong people management; deep understanding of GCP/GLP/GVP regulations and guidance across worldwide jurisdictions.
- Strong interpersonal, written/oral communication, influencing/collaboration; team player with compliance focus; highly motivated.
- 15+ years clinical sponsor QA experience; 8+ years in GCP management (sponsor company).
- Experience hosting inspections across multiple jurisdictions (e.g., FDA, Canada, EMA, MHRA, Asia).
- Experience managing people across sites/locations.
Compensation
- Annual base salary: $252,000–$269,000; eligible for annual performance pay bonus.