Audit Lead

Overview

The GMP/GDP Audit Lead will design, deliver, and maintain audit strategy across key technology and business areas including sterile biologic, medical device (software as a medical device and digital health/medicine), small molecule, vendor, and GDP.

This role leads independent GMP/GDP audits, inspection preparation, and resolution of audit findings. It partners closely with Pfizer Global Supply, Pharm Sci teams, and RQA stakeholders to align audit expectations with regulatory requirements and Pfizer’s manufacturing and supply capabilities.

• Lead strategy, delivery, and maintenance of audits for technology or business areas.
• Develop and implement technology‑focused audit plans to address emerging risks and regulatory trends.
• Co‑operate with RQA and site‑based auditors, coaching and developing audit competencies.
• Review and approve audit reports, ensuring alignment and calibration of risk and auditor development.
• Partner with GSI, Compliance, and Technology Engineering teams to evaluate new technologies and regulatory changes.
• Develop audit strategy/plans for highly complex audits and support cross‑functional projects.
• Lead or participate in GMP/GDP audits at Pfizer facilities, contract manufacturers, suppliers, and process audits.
• Assess compliance with GMP/GDP requirements, guidelines, and Pfizer standards, reporting risks or weaknesses.
• Maintain current knowledge of regulations, guidelines, and international standards (FDA, EU Directive, ICH, TGA, PIC/S, ISO).
• Collaborate proactively with RQA, site leadership, and SMEs to execute objective audits and evaluate CAPAs.

• Bachelor’s Degree in pharmaceutical sciences or equivalent.
• Minimum 10 years of progressive, challenging experience in pharmaceutical, biopharmaceutical, and medical device industry, including quality control/assurance, manufacturing, and GMP/GDP auditing.
• Experience in aseptic manufacturing and must have audited at least three technology areas.
• Strong knowledge of GMP/GDP requirements and global regulations.
• Proficiency in business, leadership, relationship, and technical skills (critical thinking, negotiation, stakeholder management, technical writing, data analytics).
• Ability to coach audit teams, recognize risk areas, and recommend solutions.

• Master’s or advanced degree.
• Recognized audit certification (e.g., ASQ).
• Experience in site internal audit and shop floor quality assurance.
• BoH / Notified Body experience.
• Knowledge of medical device regulations.
• Experience leading cross‑region or cross‑functional audit projects.

Up to 40% travel, including domestic and international travel.

The GMP/GDP Audit Lead reports to the GMP/GDP Audit Team Lead and partners with RQA, site‑based auditors, and Pfizer stakeholders.

Pfizer is committed to equal opportunity in employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, disability, or veteran status. Pfizer complies with all applicable laws governing nondiscrimination in employment and work‑authorization verification requirements. This position requires permanent work authorization in the United States.

• 401(k) plan with Pfizer matching contributions and additional retirement savings contribution.
• Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
• Health benefits including medical, prescription drug, dental, and vision coverage.

The annual base salary ranges from $162,900 to $271,500. The role is eligible for Pfizer’s Global Performance Plan with a bonus target of 20% of base salary and participation in a share‑based long‑term incentive program.