Use Your Power for Purpose

Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.

What You Will Achieve

The Sr QA Compliance Specialist plays a critical role in helping ensure the organization maintains a state of inspection readiness and compliance with global regulatory requirements (FDA, EMA, MHRA, etc.). This individual will lead and customer audits, and support regulatory inspections, internal audits, and compliance initiatives. 

This position is responsible for supporting regulatory inspection activities at the McPherson site, including preparation activities, participation during inspections, commitment assignment activities, and collection of information needed for agency and / or third-party communications.  

This role requires strong collaboration across departments to identify, mitigate, and prevent compliance risks while fostering a culture of quality and continuous improvement.

• Audit & Inspection Management

  • Serve as a primary QA lead during customer audits.

  • Coordinate pre-audit/inspection readiness activities, including logistics, documentation preparation, and staff training.

  • Act as a front-room and/or back-room representative, ensuring accurate, timely responses to auditor/inspector queries.

  • Develop and maintain inspection readiness tools, trackers, and playbooks.

• Compliance & Quality Systems Oversight

  • Monitor compliance with applicable GMP regulations, corporate policies, and industry standards.

  • Partner with cross-functional teams to ensure effective and sustainable remediation of compliance gaps.

• Customer & Regulatory Interface

  • Ensure timely and accurate responses to customer quality questionnaires, audits, and follow-up requests.

  • Support the preparation of regulatory submissions and responses to health authority inquiries as needed.

  • Serve as Data Integrity Liaison.

  • Champion a culture of compliance, accountability, and proactive quality management.

• Ensures that the site is compliant with McPherson and Pfizer corporate requirements and policies, as well as Industry Regulatory Standards. 

• Organizes the authoring of cross-functional SME responses to Inspection/Audit reports as needed ensuring compliance with applicable PGS standards and best practices.

• Supports other compliance inspection readiness and continuous improvement initiatives as assigned by Manager.

• Quality approver for PDOCs documents.

• Quality approver for Commitment Tracking (CT) module in Quality Management System.

• Evaluate corrective and preventive action responses to audit findings for adequacy and timeliness.

• Other duties within the compliance department as required.

Here Is What You Need

(Minimum Requirements)

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with more than 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.

• Prior experience in the pharmaceutical and/or manufacturing industry, preference in documentation, Quality, and/or Quality Systems (i.e., QTS, PDOCs, etc.).

• In-depth knowledge of global GMP regulations (FDA, EMA, ICH, MHRA, etc.).

• Excellent communication skills, with ability to interface confidently with auditors, inspectors, and senior leadership.

• Detail oriented with hands on experience with Microsoft Office (Word, Excel, PowerPoint).

• Independent thinker with strong organizational and analytical skills, thinking from both a tactical and strategic basis for site-based projects or global programs.

• Must have good organizational, presentation, meeting facilitation, project/time management and technical writing skills.

Bonus Points If You Have

(Preferred Requirements)

• Previous experience directly supporting and interacting with Regulatory Inspections

• Strong interpersonal skills and the ability to communicate effectively with all levels of the organization

• Ability to adapt to changing priorities and manage multiple tasks simultaneously

• Experience in mentorin