Quality Operations & Compliance Director

About the role

The Quality Operations & Compliance Director provides strategic leadership for the Pharmaceutical Quality Management System (PQMS) and ensures that manufacturing activities meet global regulatory and GMP standards. Working closely with Supply Chain, Quality Control, Manufacturing Operations and senior leadership, the role drives timely, compliant and safe product releases.

Key responsibilities

• Define and oversee the PQMS, ensuring alignment with local, European and international GMP requirements.
• Partner with Supply Chain, QC and Manufacturing to guarantee compliant and on‑time product release.
• Lead, mentor and develop a high‑performing Quality team.
• Drive inspection readiness and act as the primary Quality SME during EMA, FDA and other Health Authority inspections.
• Establish proactive regulatory intelligence processes to monitor emerging GMP regulations.
• Own and continuously improve the Data Integrity program across all PQMS interfaces (ALCOA+ compliance).
• Lead Quality Operations Management Review, presenting quality objectives and KPIs to senior management.
• Manage third‑party quality oversight to ensure external operations meet internal PQMS expectations and regulatory filings.

Required profile

• Bachelor’s and Master’s degree in Chemistry, Chemical Engineering, Pharmacy, Biology or a related scientific discipline.
• 20+ years of progressive experience in Quality Operations, Quality Compliance or related functions within the pharmaceutical industry.
• Proven experience leading large, cross‑functional quality teams and managing complex regulatory inspections.
• Strong knowledge of GMP, regulatory requirements (EMA, FDA, WHO, PIC/S) and data integrity principles.

Required skills

• Deep understanding of GMP compliance and regulatory frameworks.
• Experience with Data Integrity programs (ALCOA+ principles).
• Expertise in regulatory intelligence and Quality Risk Management.