Senior Director, Clinical Quality Assurance

Alkermes

22h

About The Position

This Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight of Alkermes GLP/GCP/GVP quality programs to ensure compliance across global clinical trials. This leader ensures the organization is ready for inspections, implements and manages risk-based quality systems, collaborates across departments to advance development programs, and supports the team for NDA/BIMO milestone achievements. This role requires an experienced Clinical QA Senior leader who can build high‑performing teams, influence in a matrixed environment, anticipate and respond to evolving regulatory expectations. Responsible for the Clinical Quality Assurance (CQA) unit within the Alkermes organization. The CQA unit consists principally of a team based out of Waltham supported by individuals across the sites and Contract Auditors on “an-as-required” basis. A member of the Alkermes Quality leadership team responsible for overall Quality culture and continuous improvement of Alkermes QMS and compliance, and leads the Alkermes strategy and GXP compliance on all matters concerning Quality in the areas of; Good Laboratory Practices (GLP), Good Clinical Practices (GCPs), and Good Pharmacovigilance Practices pre and post market (GVPs). Directs a team in the development of all applicable; risk-based audit programs, inspection readiness and hosting of Health Authority Inspections.

Requirements

Bachelor's Degree level or above in a science discipline.
Bachelor’s degree in life sciences, pharmacy, nursing or a related field
Strong understanding of, and experience in personnel management, with particularly strong scientific skills, while having an excellent understanding of GCP, GLP and GVP practices, regulations, guidances and associated industry standard technology platforms, across all worldwide jurisdictions where Alkermes sponsors clinical trials.
Strong interpersonal skills
Team player with flexibility without compromising compliance
Strong communicative skills (written and oral).
Influencing and collaboration skills
Highly motivated.
15+ years’ experience gained within an organization pursuing a high throughput of clinical sponsor activity with at least 8 years experience in GCP management with a Sponsor company.
Excellent understanding of GLP, GCP, and GVP requirements as they apply to the industry across a range of jurisdictions.
Experience in hosting regulatory inspections across multiple jurisdictions (eg FDA, Canada, EMA, MHRA, Asia)
Experience in people management across sites and locations.
Logical and problem solving skills
High level of customer orientation/understanding
Ability to work and get results through Matrixed teams

Responsibilities

Develop and execute a clinical QA strategic vision aligned to business and program objectives.
Develop and lead Risk Management assessments with Clinical R&D and commercial safety departments to ensure standards and practices are managing risks and ensuring patient safety (during clinical trials and ultimately as consumers of marketed products).
Establish and track goals, budgets, headcount plans, and performance metrics for the Clinical QA function. Fully determine and justify the teams’ budgetary requirements (Expenses, FTE, and CAPEX)
Provide thought leadership by anticipating regulatory changes, industry trends, and evolving GCP/GVP/GLP expectations.
Serve as the senior Clinical QA representative on program teams, sub teams, and study teams.
Ensure all GCP/GVP/GLP activities meet global regulatory, quality, and compliance standards for clinical trials.
Apply Critical to Quality (CtQ) principles, in line with ICH E8(R1) (Quality by Design) and ICH E6(R2/R3), to guide trial level risk assessments, audit strategy, oversight activities, and inspection readiness.
Oversee the development, implementation, and continuous improvement of clinical quality systems, harmonized GCP/GVP/GLP Policies, processes, SOPs, and governance structures collaborating closely with Clinical Department, related functions and external partners to comply with global requirements.
Ensure appropriate division and touchpoints with GMP.
Lead the design and execution of a risk based GCP/GVP/GLP audit program covering internal audits, CROs, vendor audits, and clinical site audits (routine and for cause).
Assess audit findings for impact on subject safety, data integrity, compliance and business operations, and ensure timely CAPA development and closure.
Lead GCP inspection readiness initiatives, including mock BIMO interviews, inspection preparedness plans, and cross functional training.
Manage BIMO sponsor inspections and provide oversight/support for CRO inspections.
Partner with Clinical Operations, Medical Affairs, Pharmacovigilance and Safety, Regulatory Affairs, Biostatistics, Data Management, CROs, vendors, and clinical sites to ensure operational compliance.
Review and contribute to key clinical and regulatory documents including INDs, protocols, IBs, NDAs, and other submission related materials.
Implement and maintain a risk based GCP/GLP/GVP oversight strategy encompassing trial conduct, site compliance, data integrity, and safety reporting.
Support investigations of site deviations, protocol noncompliance, and GCP violations, ensuring thorough root cause analysis, CAPA effectiveness, and proper documentation/data integrity.
Identify and escalate compliance risks, recommending mitigation plans to Clinical Development and Quality leadership.
Lead or oversee GCP training programs across the organization.
Communicate regulatory changes, best practices, and compliance expectations to internal stakeholders.
Lead, mentor, and develop Clinical QA personnel, promoting a culture of accountability, collaboration, and continuous improvement.
Select and manage qualified resources to support the QMS and ensure delivery of company goals.