Executive Director, Clinical Quality Assurance

Green Key Resources

Massachusetts

On-site

USD 180,000 - 240,000

Full time

13 days ago

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Job summary

Alkermes is seeking a Sr. Director of Clinical Quality Assurance to provide strategic leadership and oversight of GLP/GCP/GVP quality programs across global trials.

You will ensure inspection readiness, advance risk-based QA systems, and collaborate with Clinical Operations, Regulatory, and Safety to support NDA/BIMO milestones. The role requires a seasoned clinical QA leader capable of building high-performing teams, influencing in a matrixed environment, and anticipating evolving regulatory

Qualifications

Bachelor's Degree in life sciences, pharmacy, nursing or related field.
15+ years in clinical sponsor activity with at least 8 years in GCP management.
Experience hosting regulatory inspections across multiple jurisdictions (FDA, EMA, etc.).
Strong understanding of GLP, GCP, and GVP requirements as they apply to industry.
Excellent interpersonal and communication skills; ability to influence in a matrixed environment.

Responsibilities

Provide strategic leadership and governance for Clinical QA, aligning vision with program objectives.
Own and improve clinical quality systems, policies, SOPs and governance for global trials.
Lead risk-based audit programs across internal functions, CROs, vendors and sites; ensure CAPA effectiveness.
Partner with Regulatory, Clinical Operations, Medical Affairs and Safety to ensure compliance across functions.
Oversee training programs and readiness activities; cultivate high-performing QA teams.
Manage resources, budgets, headcount, and performance metrics for Clinical QA.

Skills

Leadership

GCP/GLP/GVP

Audit management

Regulatory knowledge

Cross-functional collaboration

Communication skills

Strategic thinking

People management

Risk assessment

Education

Bachelor’s degree in life sciences or related field

Job description

Our BioPharma client with commercial products and an impressive pipeline is seeking the following high impact person:

Sr. Director of Clinical Quality Assurance

This Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight of 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 organization. The CQA unit consists principally of a team supported by individuals across the sites and Contract Auditors on “an-as-required” basis.

A member of the Quality leadership team responsible for overall Quality culture and continuous improvement of QMS and compliance; leads 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.

Responsibilities

Strategic Leadership & Governance

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.

Clinical Quality System Ownership & Compliance Oversight

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.

Audit & Inspection Management

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.

Cross Functional Collaboration

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 escalation compliance risks, recommending mitigation plans to Clinical Development and Quality leadership.

Training & Organizational Readiness

Lead or oversee GCP training programs across the organization.
Communicate regulatory changes, best practices, and compliance expectations to internal stakeholders.

Management Responsibilities

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.

Qualifications

Basic Qualifications

Bachelor's Degree level or above in a science discipline. Bachelor’s degree in life sciences, pharmacy, nursing or a related field

Preferred Qualifications

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, guidance’s 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.

Experience

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.

Abilities and Judgement