Director GMP QA

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This role will oversee quality operations, vendor compliance, regulatory readiness, and support for clinical development and manufacturing activities, ensuring alignment with global health authority requirements.

Key Responsibilities:

• Lead QA team and quality systems for GMP/GLP compliance
• Manage audits, regulatory inspections, and CAPA processes
• Oversee vendor and contract partner quality performance
• Contribute to regulatory submissions and inspection preparedness
• Advise leadership on quality strategy and risk management

Qualifications:

• 10+ years in QA leadership within biopharma, ideally with small molecule experience
• Strong knowledge of global GMP/GLP regulations (FDA, EMA, ICH, etc.)
• Experience with CDMOs, regulatory submissions, and quality systems
• Strong leadership, communication, and problem-solving skills

Details:

Candidates must be local. Hybrid on-site work model with limited travel.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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