Director Quality GCP

Vor 2 Tagen

Basel, Basel-Stadt, Schweiz Axepta Vollzeit CHF 90'000 - CHF 120'000 pro Jahr

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.

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