Quality Compliance lead

Position Summary

• Ensure GMP standards compliance in line with Pfizer requirements

• Maintain systems meeting company, ISO and regulatory requirements

• Lead Training System and Supplier Management

• Manage inspection readiness

• Drive Data Integrity program and improvements

Site Data Integrity Lead

• Integrate data integrity requirements into system validation lifecycle

• Ensure compliance with Pfizer Quality Standards

• Implement and monitor Data Integrity program

• Maintain continuous improvement of DI plan

• Conduct audits and investigations related to DI

Site Training Lead

• Ensure compliance of Training Quality System

• Manage GMP training (materials, assessment, curricula)

• Maintain LMS and training records

• Define retraining and track training metrics

• Drive continuous improvement of training system

Supplier Management System / Qualification

• Collaborate with procurement and QA for supplier qualification

• Manage supplier audits and agreements

• Use Supplier Management System (SMS)

Audit

• Establish and execute internal audit program

• Act as lead auditor when required

• Review audit reports and CAPAs

• Ensure audit team competency

• Maintain audit documentation

Quality System

• Oversee CAS reports and Pfizer Quality System implementation

• Review change controls for compliance

Organizational Relationships

• Reports to: Site Quality Lead

• Key interactions: Site colleagues, suppliers, global network

Education

Bachelor’s Degree , Master ‘s Degree, PharmD, or equivalent qualification in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology, Biotechnology, Engineering, or a related scientific discipline.

• Fluent in French and English, both written and verbal.

Experience

• Minimum 5 years of experience in the pharmaceutical industry within Quality Systems including more than 2 years within Quality Compliance.

• Proven experience managing Quality Systems including Data Integrity, Training, Supplier management and qualification, and Documentation Management.

• Experience supporting regulatory inspections, internal audits, external audits, and inspection readiness activities.

• Demonstrated ability to work effectively in cross-functional and matrix organizations while influencing stakeholders at different levels.

• Experience leading quality and compliance improvement initiatives and driving a culture of compliance and continuous improvement.

Technical Skills

• Strong knowledge of cGMP, and Data Integrity principles (ALCOA+).

• Experience with electronic Quality Management Systems (eQMS), TrackWise, gQTS, and document management systems, Supplier management system. 

• Ability to perform compliance assessments, quality trend analysis, and risk-based decision making.

• Strong technical writing skills for procedures, investigation reports, Change Control, risk assessments, and audit responses.

• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Teams, and SharePoint). 

• Strong communication, project management, and stakeholder management skills.

  
 

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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Quality Assurance and Control