Quality Compliance Lead

About the role

The Quality Compliance Lead is responsible for ensuring that all GMP standards are met in line with Pfizer's requirements. This role oversees data integrity, training, supplier management, and audit readiness across the site, driving continuous improvement and regulatory compliance.

Key responsibilities

• Maintain systems that meet company, ISO, and regulatory requirements.
• Lead the Data Integrity program, integrate requirements into system validation, and conduct related audits.
• Manage the training quality system, including curriculum development, LMS maintenance, and training metrics.
• Collaborate with procurement and QA to qualify suppliers, conduct supplier audits, and manage agreements.
• Establish and execute an internal audit program, act as lead auditor when needed, and ensure audit documentation is up‑to‑date.
• Oversee quality system implementation, review change controls, and ensure compliance with Pfizer Quality Standards.

Required profile

• Minimum 5 years of experience in the pharmaceutical industry, with at least 2 years in Quality Compliance.
• Proven experience managing Quality Systems, Data Integrity, Training, Supplier Management, and Documentation.
• Experience supporting regulatory inspections, internal and external audits, and inspection readiness.
• Strong ability to work in cross‑functional, matrix environments and influence stakeholders.
• Fluent in French and English, both written and verbal.

Required skills

• Strong knowledge of cGMP and Data Integrity principles (ALCOA+).
• Experience with electronic Quality Management Systems (eQMS), TrackWise, gQTS, and document management systems.
• Proficiency with Supplier Management Systems.
• Advanced use of Microsoft Office Suite (Excel, Word, PowerPoint, Teams, SharePoint).
• Technical writing for procedures, investigation reports, change controls, and audit responses.