Job Description

For our client, a rapidly scaling biopharmaceutical organization is seeking a senior Director, Quality GCP (Contractor) to reinforce its global Quality function during a critical Phase 3 clinical program.

This mission is ideal for an experienced GCP Quality Consultant who thrives in high-impact environments, brings strategic and operational oversight, and can step in quickly with full autonomy.

Director, Quality GCP - Contracting

Responsibilities

Acting as the lead GCP Quality expert, you will support global clinical activities while ensuring compliance, risk management, and inspection readiness.


You will:

Serve as the primary GCP QA contact for CROs, vendors, and investigator sites. Manage and assess GCP quality events, including potential serious breaches, CAPAs, Change Actions, and effectiveness checks. Develop and maintain a risk-based GCP compliance program tailored to ongoing Phase 3 needs. Author/update GCP SOPs and act as senior reviewer for cross-functional GxP procedures. Deliver GCP/GxP training across internal and external teams. Oversee vendor qualification, conduct and supervise audits (CROs, central labs, sites). Lead the audit program and ensure timely tracking and remediation of findings. Provide strategic QA GCP input into regulatory submissions. Drive inspection readiness for global regulatory authorities (FDA, EMA, MHRA). Collaborate closely with Clinical Ops, Regulatory, Data Management, and external suppliers.

Profile

You are an accomplished GCP Quality Consultant with the seniority and autonomy required for a high-stakes Phase 3 program.

10+ years in pharma/biotech, including significant Phase 3 clinical development exposure. Strong expertise in global GCP regulations (FDA, EMA, MHRA) and deep familiarity with ICH E6(R3). Proven track record in CRO audits, vendor oversight, and audit program leadership. Hands-on and solution-oriented, able to manage complex issues with independence and speed. Used to operating in fast-moving, matrixed, and scaling biotech environments. Strong prioritization and multi-tasking capabilities. Understanding of drug development, QMS, and program management is advantageous. * Excellent communicator able to influence internal and external stakeholders.