Associate Director, GCP Quality Assurance

Job Summary:

The Associate Director, GCP Quality Assurance is responsible for providing strategic and operational Quality Assurance oversight for Good Clinical Practice (GCP) activities supporting the company’s clinical development programs. This role ensures that clinical trials are conducted in compliance with applicable regulatory requirements, company policies, and global GCP standards, with a continuous state of inspection readiness.

The Director partners closely with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, and external service providers to implement a risk-based quality oversight model across the clinical lifecycle. The role is accountable for GCP quality systems, vendor oversight, audits, and inspection support, and plays a critical role in embedding quality by design into clinical development programs.

Work Arrangement & Location:

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Develop and implement the GCP QA strategy aligned with clinical development objectives and global regulatory expectations
• Serve as a key QA partner to Clinical Operations and cross-functional stakeholders on GCP compliance and quality risk management.
• Promote a strong culture of quality, compliance, and continuous improvement across clinical programs.
• Oversee GCP quality systems including deviations, investigations, CAPAs, change control, documentation, and training related to clinical activities.
• Ensure GCP processes are phase-appropriate, compliant, and scalable.
• Support the development, review, and approval of GCP-related SOPs, policies, and work instructions.
• Provide QA oversight for GCP activities conducted internally and by CROs, vendors, and other service providers.
• Lead GCP vendor qualification, audit strategy, and ongoing oversight using risk-based principles.
• Review and approve GCP-related quality agreements and vendor oversight plans.
• Plan and execute risk-based GCP audits, including CRO audits, investigator site audits, and system audits as applicable
• Lead GCP inspection readiness activities and serve as a primary QA contact during health authority inspections.
• Coordinate inspection preparation, conduct, and follow-up, including responses to regulatory observations.
• Perform other duties and responsibilities as assigned.

Qualifications:

• Education: Bachelor's degree required in a scientific or technical discipline (Life Sciences, Chemistry, Engineering, or related field); advanced degree strongly preferred.
• 7+ years of experience in GCP Quality Assurance or Clinical Quality within a biotech or pharmaceutical environment.
• Strong knowledge of global GCP regulations and clinical trial oversight requirements.
• Demonstrated experience supporting regulatory inspections and audits.
• Experience overseeing CROs and other GCP service providers.
• Experience supporting late-stage or pivotal clinical trials.
• Strong background in risk-based quality management and inspection readiness.
• Ability to balance compliance with operational execution
• Commitment to patient safety, data integrity, and quality culture
• Strong cross-functional collaborator who proactively communicates quality risk, escalates issues with appropriate context and urgency, and fosters a culture of transparent, solution-oriented dialogue.