Senior QA Compliance and Auditing Specialist I

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 involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.  

The Senior QA Compliance Specialist is a senior contributor to the Quality Systems and Compliance department with responsibility supporting Pfizer’s ability to maintain compliance with market regulations and expectations. The incumbent is responsible for coordinating and executing internal audits at the U.S. Pfizer sites per applicable global procedures.  The Senior QA Compliance Specialist will also support Board of Health (BOH) inspections and customer audits, including inspection readiness initiatives at the Andover site, applying sound technical and quality knowledge to interpret and apply regulations/requirements across a broad range of cGMP activities.  The Senior QA Compliance Specialist makes complex and routine decisions with minimal guidance from management.

What You Will Achieve

In this role, you will:

• Lead and support internal audits at the U.S. Pfizer sites to ensure compliance is maintained according to Pfizer global and site procedures, GMP regulations and guidance.  This includes audit preparation, audit execution, audit report writing and finding classification, and review of responses. 
• Provide support with Board of Health inspections and customer audits.
• Collaborate with cross-functional compliance leads and colleagues across the Andover site to always ensure inspection readiness, including performing periodic facility, QC Laboratory, and warehouse walkthroughs.
• Provides guidance, lead/co-lead projects, manages own time to meet objectives, and plan resource requirements for projects across Quality Systems & Compliance.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience 

• Must be willing to travel (up to 25%) to U.S. Pfizer sites or internationally, as needed

• Proficient in compliance and regulatory requirements for Pharmaceutical manufacturing

• Knowledge of GMP regulations/guidances as they pertain to the pharmaceutical/biopharmaceutical industry

• Ability to identify compliance issues resulting from cGMP deviations or product defects

• Knowledge and experience with quality systems and processes

• Proactive approach and strong critical thinking skills

• Strong collaboration, relationship management, and interpersonal skills

• Excellent written and verbal communication

• Advanced computer skills in MS Office applications and good knowledge of enterprise systems (e.g., electronic Quality Management System)

• Knowledge and use of AI (e.g., CoPilot)

Bonus Points If You Have (Preferred Requirements)

• Previous auditing experience including supporting Health Authority inspections
• ASQ Certification
• Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
• Knowledge or exposure to data science
• Strong leadership and team management skills
• Ability to work under pressure and meet tight deadlines
• Ability to influence and negotiate with stakeholders
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

PHYSICAL/MENTAL REQUIREMENTS

Office job involving computer use. In addition to the following requirements: Gowning into manufacturing suites, lifting, sitting, standing, walking and bending.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Able to travel up to 25% to U.S. Pfizer sites.  Some international travel may be required. 
• Additional support outside normal business hours may be required (e.g., BOH inspections)

OTHER JOB DETAILS

Last Date to Apply for Job: June 11, 2026.

Referral Bonus E