Associate Director, Quality Assurance GCP

Role Summary

The Associate Director, Quality Assurance GCP supports the Good Clinical Practice (GCP) Quality Assurance function and performs day-to-day GCP QA operations. They will execute and oversee GCP QA activities, perform external and internal audits, support clinical studies from phase 1 to phase 4, review study documents, support regulatory inspections, and enhance GCP QA infrastructure. In alignment with updated ICH E6(R3) expectations, the role emphasizes flexible, proportionate, and risk-based quality oversight, maintains inspection readiness, and leads proactive, data-driven quality management to identify and mitigate quality risks.

Responsibilities

• Manage or perform clinical site, internal, TMF, GCP, and GLP vendor audits.
• Generate and/or review GCP and GLP QA audit plans and schedules, tailoring scope and depth to study/process risk and complexity.
• Generate and/or review and approve audit trend reports across programs to identify systemic issues and drive preventive actions.
• Communicate, address, and prevent identified GCP compliance issues and trends.
• Develop and manage audit programs.
• Represent QA at program-wide meetings and provide GCP guidance and feedback.
• Serve as point of escalation for GCP compliance issues identified by clinical study teams or QA leads, and inform the head of QA and Management.
• Embed Quality‑by‑Design (QbD) and Critical‑to‑Quality (CtQ) principles into study planning and execution to prevent errors that matter.
• Investigate, manage, and track GCP CAPAs, deviations, and other quality issues.
• Collaborate with cross-functional teams to help ensure and strengthen data integrity, data governance, digital traceability, and participant protection.
• Assist with serious breach assessments and notifications per regional requirements.
• Provide guidance and support to Trial Master File activities.
• Review study-specific documents.
• Partner with cross-functional groups and promote compliance.
• Attend governance meetings.
• Identify and address quality systems gaps, including internal process improvements.
• Author, review, or revise SOPs, Work Instructions, Policies, and/or Job Aids.
• Deliver training to internal and external stakeholders.
• Support regulatory inspections and inspection readiness activities.
• Drive an inspection-readiness mindset (e.g., mock interviews, inspections, storyboards, document triage, front-room/back-room orchestration).
• Prepare clinical sites for inspection readiness.
• Review clinical study documents.
• Support other Quality Assurance and Quality Systems activities.
• Develop compliance strategies.
• Provide input and expertise in vendor selection and oversight.
• Prepare and/or assess key quality metrics to support continuous improvement and timely escalation of issues.
• Draft and recommend Quality Agreements for GCP/GLP vendors.
• Direct/supervise personnel; including coaching, mentoring, development, performance management, and administrative tasks.
• Other duties as assigned.

Qualifications

• Required: Bachelor's degree in a science discipline and at least 10 years’ experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered) with a minimum of 7 years’ supervisory/leadership experience.
• Required: Minimum of 5 years of working in a QA GCP function.
• Required: Previous experience in inspection readiness and audits.
• Required: Previous experience in developing and implementing compliance activities.
• Required: Proven ability to cultivate and develop relationships with cross-functional teams, vendors, sites, and other stakeholders.
• Required: Proven ability to interpret applicable FDA, EU and ICH guidelines related to GCP.
• Required: Strong working knowledge of GCP regulations.
• Required: Able to assess issues, perform thorough analysis on complex investigations, and resolve issues in a diplomatic and expeditious manner.
• Preferred: GVP and GLP knowledge, a plus.
• Preferred: Auditor certification and/or RQAP-GCP certification, a plus.
• Preferred: Strong interpersonal/collaboration, organization, and multi-tasking skills.

Additional Requirements

• Travel: You may be required to travel for up to 40% of your time.
• Physical Demands: On a continuous basis, sit at a desk for long periods; intermittently answer telephone and use a keyboard. Some walking and lifting up to 25 lbs may be required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.