Head of International Market Quality & Compliance

About the role

As the Head of International Market Quality & Compliance, you will lead the strategic and operational performance of the international quality and compliance function, ensuring delivery of business objectives while meeting regulatory requirements.

Key responsibilities

• Manage the department budget while maintaining an efficient organization.
• Lead quality and compliance activities with nominated third parties to ensure Life Cycle Management of pharmaceutical products in line with corporate GMP Quality Policy and international regulatory requirements.
• Oversee third‑party quality management, release activities and change controls, conducting batch assessments to guarantee timely and compliant releases.
• Direct the qualification program for suppliers and subcontractors from GMP and GDP perspectives, approving subcontracted activities that may impact compliance.
• Generate and evaluate strategic options for third‑party collaborations using GMP compliance, business, and financial analysis.
• Verify GMP compliance status of all parties in the global supply chain and ensure alignment with marketing authorizations.
• Develop, supervise, monitor, and continuously improve the quality risk management program, including complaints, deviations, and risk assessments.
• Implement and manage Pharmascience’s international quality system and support regulatory file preparation for submissions.

Required profile

• Extensive experience in pharmaceutical quality assurance and regulatory compliance.
• Strong knowledge of GMP, GDP and international regulatory frameworks.
• Proven track record in supplier qualification and third‑party management.
• Ability to lead cross‑functional teams and manage budgets.
• Experience with quality risk management, audit processes, and change control procedures.

Required skills

• Good Manufacturing Practice (GMP)
• Good Distribution Practice (GDP)
• Quality risk management
• Supplier qualification
• Regulatory compliance
• Auditing
• Change control management
• Batch release assessment