QA Compliance Lead

About the role

The QA Compliance Lead will provide strategic oversight of quality and compliance activities across the site, ensuring alignment with cGxP requirements. Reporting to senior management, the role drives a strong quality culture and partners with manufacturing, technical operations, regulatory and global quality teams.

Key responsibilities

• Lead overall Quality Compliance activities in line with cGxP standards.
• Act as senior quality authority for audits, inspections and health‑authority interactions, maintaining inspection readiness.
• Own and continuously improve the Quality Management System, including deviations, CAPAs, change control and data integrity.
• Govern GxP risk management, incident handling and compliance remediation.
• Provide regulatory and quality oversight of site activities, suppliers and service providers.
• Champion a quality‑first culture, modeling integrity, accountability and patient focus.
• Collaborate closely with senior stakeholders across Manufacturing, Technical Operations, Regulatory and Global Quality.
• Coach and develop senior quality professionals to ensure expertise continuity.
• Drive Lean Leadership and operational‑excellence initiatives.

Required profile

• Minimum 10 years of progressive experience in Quality Assurance and Compliance within a GMP‑regulated pharmaceutical environment.
• Proven senior QA leadership experience with responsibility for compliance strategy and inspection outcomes.
• University degree in Pharmacy (or related field).
• Fluent English is a strong advantage.

Required skills

• cGMP knowledge.
• Quality Management System (QMS) expertise.
• CAPA and change‑control processes.
• Data integrity principles.
• GxP risk‑management techniques.
• Lean leadership methodologies.