Compliance associate

Use Your Power for Purpose

Everything we do, every day, is in line with an unwavering commitment to quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What Will You Achieve

You will contribute to maintaining a strong and sustainable compliance culture across the site, ensuring alignment with Pfizer Quality Standards, Good Manufacturing Practices (GMP), applicable regulatory requirements, and site procedures.

You will support key compliance programs, including Training, Supplier Management and Qualification, External Supplier Audits, Data Integrity, Inspection Readiness, and Quality Systems.

You will contribute to the development, implementation, maintenance, and continuous improvement of quality programs and processes to ensure ongoing compliance with established standards and regulatory requirements.

Your contribution to Quality Risk Management will support compliance commitment tracking, interpretation of policies and requirements, and effective oversight of site compliance activities.

You will work closely with local and global cross-functional teams to monitor compliance, identify improvement opportunities, share best practices, and ensure timely implementation of required actions.

 In this role, you will:

• Coordinate the Site Training System, including training curricula, GMP training, learning assessments, training records, qualification requirements, and training compliance metrics.
• Partner with departments to ensure appropriate training requirements are defined, maintained, and deployed in a timely manner.
• Support the Supplier Management System and Supplier Qualification Program, including supplier qualification, audit requests, Quality Agreements, and follow-up activities.
• Participate in External Supplier Audits, including the review of audit reports, CAPA action plans, and follow-up of audit commitments.
• Support the site's Inspection Readiness Program to maintain a continuous state of readiness for regulatory and internal inspections.
• Support Quality System activities, including monitoring compliance requirements and reviewing changes for alignment with the Pfizer Quality System.
• Participate in coordinating Data Integrity awareness and training activities and support the follow-up of identified gaps and corrective actions.
• Support the implementation and continuous improvement of the Site Data Integrity Program, including assessments, remediation activities, and adherence to ALCOA+ principles.
• Ensure compliance with Pfizer Quality Standards, GMP requirements, and applicable regulatory requirements.
• Collaborate with cross-functional teams locally and globally, actively participating in cross-site forums and initiatives and contributing to continuous improvement across the Pfizer network.

Here Is What You Need

• Master’s or Bachelor’s degree in Pharmacy, Biology, Chemistry, Engineering, or another relevant scientific discipline, with at least 2 years of relevant experience.
• Relevant experience in the pharmaceutical industry is required; experience in Compliance, Quality Assurance, or Quality Control would be an advantage.
• Good understanding of Good Manufacturing Practices (GMP) and pharmaceutical quality systems.
• Strong understanding of regulatory requirements and compliance standards.
• Knowledge or experience in Data Integrity and ALCOA principles.
• Knowledge of Quality Risk Management processes.
• Excellent attention to detail and organizational skills.
• Strong analytical and problem-solving skills with a continuous improvement mindset.
• Ability to manage multiple priorities and meet agreed timelines.
• Effective written and verbal communication skills in both English and French.
• Ability to collaborate effectively with cross-functional teams.
• Proficiency in Microsoft Office applications, particularly Excel, PowerPoint and Word.

Bonus Points If You Have:

• Knowledge of Data Integrity controls for GMP equipment and computerized systems, including audit trails, access management, and ALCOA+ principles.
• Experience participating in GMP audits or regulatory inspection readiness activities.
• Knowledge of Supplier Management and Supplier Qualification processes.
• Experience with pharmaceutical training systems or Learning Management Systems (LMS).
• Familiarity with electronic Quality Management Systems (eQMS) and digital quality tools.
• Experience using AI tools, such as Microsoft Copilot, to enhance productivity and problem-solving, with an understanding of responsible, ethical and compliant AI use.

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.

 

 

Quality Assurance and Control