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.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.