Quality Compliance Associate

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. Our dedication to quality and safety drives everything we do, fostering a dynamic environment where your role is crucial in advancing healthcare solutions.

What You Will Achieve

In this role, you will:

• Serve as a key resource within the Quality Compliance organization, supporting site inspection readiness and ensuring compliance with Pfizer and regulatory requirements.
• Support the Quality Compliance Supervisor in maintaining the site in a stable, audit-ready, and inspection-prepared state.
• Manage personal priorities and assigned compliance activities while taking accountability for delivering accurate, timely, and effective results.
• Support the execution of the Internal Audit Program, including self-assessments, internal audits, walkthroughs, report preparation, and follow-up of corrective and preventive actions.
• Contribute to maintaining the site Inspection Readiness Program and support internal audits, external inspections, customer audits, and regulatory authority inspections.
• Assist departments in implementing improvements resulting from audit findings, inspection observations, and compliance gap assessments.
• Support supplier quality management activities, including supplier qualification, maintenance of approved supplier lists, quality agreement review, and supplier audits.
• Prepare and monitor Quality Compliance metrics and dashboards to evaluate quality system performance and drive continuous improvement.
• Support implementation and continuous improvement of the site's Data Integrity Program, ensuring compliance with ALCOA+ principles and Pfizer requirements.
• Participate in investigations, perform root cause analyses, and support development of effective corrective and preventive actions (CAPAs).
• Monitor commitments, CAPAs, effectiveness checks, and quality actions to ensure timely implementation and sustainable closure.
• Actively support IMEx initiatives and contribute to Structured Gemba activities and quality performance reporting.

Here Is What You Need (Minimum Requirements)

• Bachelor's Degree (BAC+3) or Master's Degree (BAC+5) in Quality Management for Bio-industries, Pharmacy, Chemistry, Biology, Biotechnology, Engineering, or a related scientific discipline.
• Recent graduates and candidates with internship, apprenticeship, or initial professional experience in the pharmaceutical, biotechnology, or regulated manufacturing industry are encouraged to apply.
• Basic knowledge of Good Manufacturing Practices (cGMP) and pharmaceutical quality systems.
• Understanding of quality compliance principles, including audits, inspections, CAPA management, Change Control, and Quality Risk Management.
• Awareness of Data Integrity principles and regulatory expectations related to electronic records and documentation.
• Strong analytical and problem-solving skills with the ability to identify issues and propose practical solutions.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a cross-functional team environment.
• Strong organizational skills and attention to detail.
• Ability to manage multiple priorities and work independently when required.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Willingness to learn and develop expertise in quality compliance systems and regulatory requirements.

Bonus Points If You Have (Preferred Requirements)

• Internship, apprenticeship, or first professional experience in Quality Assurance, Quality Control, Quality Compliance, or pharmaceutical manufacturing.
• Exposure to GMP-regulated environments through academic projects, internships, or work experience.
• Knowledge of Data Integrity concepts and ALCOA+ principles.
• Familiarity with quality systems such as Deviations, CAPAs, Change Controls, Risk Management, and Document Management.
• Experience with electronic quality management systems such as PDOCS, QTS, SMS, Vault, TrackWise, or equivalent platforms.
• Participation in internal audits, inspection readiness activities, or continuous improvement projects.
• Knowledge of Quality Risk Management tools such as FMEA.
• Strong presentation, training, and facilitation skills.
• Familiarity and basic understanding of common AI tools and a curiosity for learning how they can be used to enhance productivity.

 
Work Location Assignment: On Premise

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