Audit Lead

About the role

The GMP/GDP Audit Lead is responsible for leading the design, delivery, and maintenance of audit strategy for one of the following key technology or business-aligned areas: sterile biologic, medical device (including software as a medical device and digital health and medicines), small molecule, vendor, and GDP. This role ensures audit processes, systems, procedures, and auditor competencies align with regulatory expectations and effectively identify risks while adapting to emerging advances, regulations, and industry trends. The Audit Lead partners closely with Pfizer Global Supply (PGS) and PharmSci teams to align expectations for GMP/GDP requirements and understand Pfizer’s manufacturing and supply capabilities.

This position leads independent GMP/GDP audits, inspection preparation activities, resolution of audit and inspection findings, and liaises with Site Quality and Above Site Quality teams throughout the audit lifecycle. The role may also lead or participate in complex cross-functional projects and contributes to a culture of innovation, excellence, and continuous improvement within Pfizer’s Quality Management System.

Responsibilities

• Develop and implement technology/business-focused audit strategies to ensure procedures and guidelines remain aligned with applicable regulations and effectively identify emerging risks.
• Ensure understanding and working knowledge of all applicable regulations and emerging regulatory trends for the assigned technology area.
• Analyze regulatory intelligence, including emerging regulations and audit/inspection outcomes, to ensure audit focus areas remain relevant to advancements in technology and regulations.
• Provide holistic and sustainable action plans for audit outcomes and communicate new or emerging risks to RQA and PGS/PharmSci stakeholders.
• Coach and oversee RQA and site-based auditors, serving as a Subject Matter Expert in the assigned technology area.
• Review and approve audit reports to ensure alignment, calibration of risk, and auditor development.
• Partner with PGS Operating Units and center functions (e.g., Quality Systems and Compliance, Global Technology Engineering + Launch) to understand new technologies, provide input on Pfizer requirements, and identify emerging audit risk areas.
• Develop audit strategies/plans for highly complex audits and continuously improve audit practices.
• Represent GMP/GDP Audit in industry forums within the assigned technology portfolio.
• Lead or participate in RQA or PGS initiatives to advance the audit function’s strategy.
• Lead or participate in GMP/GDP audits at Pfizer facilities, contract manufacturers, suppliers, and process audits to assess compliance with GMP/GDP requirements, guidelines, Pfizer standards, and Quality Agreement requirements.
• Independently plan, lead, and execute audit strategies for complex process audits, interpreting regulatory and business challenges and reporting risks or weaknesses.
• Maintain and expand knowledge of applicable regulations, guidelines, and Pfizer Standards impacting auditee operations.
• Liaise between auditees and Pfizer groups to ensure pertinent information impacting business operations is assessed.
• Lead or participate in GMP/GDP assessments (e.g., due diligence, mock inspections, data integrity, quality culture) to evaluate auditee compliance.
• Aid auditees in preparing for regulatory inspections and apply technology knowledge to influence cross-functional project design, planning, and execution.
• Collaborate with RQA and site leadership to enable a culture of excellence in independent audits and CAPA evaluations.

Requirements

• Bachelor’s Degree in pharmaceutical sciences or equivalent.
• Minimum 10 years of progressive experience in the pharmaceutical, biopharmaceutical, or medical device industry, including quality control/assurance, manufacturing, and GMP/GDP auditing (may include Product Development).
• Aseptic manufacturing experience and/or expertise.
• Proven knowledge and experience in GMP/GDP auditing of at least 3 technology areas.
• Demonstrated ability to apply business skills (negotiation, logical reasoning, critical thinking, decision-making, presentation skills), leadership skills (persuasive communication, active listening, active learning), relationship skills (stakeholder management, social perceptiveness, relationship building), and supporting technical skills (technical writing, digital acumen, data analytics).
• Strong understanding of Quality Management System requirements at Pfizer facilities, contract manufacturers, suppliers, and GMP/GDP service providers.
• In-depth knowledge of relevant regulatory and audit frameworks for biopharmaceutical and medical device operations, including global regulations and internationally recognized standards (e.g., FDA, EU Directive, ICH, TGA, PIC/S, ISO).
• Ability to critically evaluate auditee information, identify risk areas, and analyze symptoms to determine potential causes and solutions.
• Strategic and tactical recommendation capabilities with effective communication across all leadership levels.
• Ability to anticipate objections, influence outcomes, and proactively propose and execute tasks.
• Ability to lead diverse audit teams and interact effectively with multicultural personnel.
• Experience leading or participating in cross-functional teams for complex projects.
• Ability to work independently, lead or participate in global audit teams, and communicate effectively with peers and leadership.
• Ability to conduct ad hoc GMP/GDP assessments to support business needs.
• Demonstrated breadth of diverse leadership experiences, including influencing, collaborating, coaching, and guiding colleagues to achieve meaningful outcomes.

Preferred Qualifications

• 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/cross-functional audit projects.

Pay

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

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holiday, and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits, including medical, prescription drug, dental, and vision coverage.
• Relocation assistance may be available based on business needs and eligibility.

Schedule

Travel Required: Ability to travel up to 40% of the time, including domestic and international travel.

Work Location Assignment: Remote