Use Your Power For Purpose
The GMP/GDP Audit Lead position is responsible for leading the design, delivery and maintenance of audit strategy associated with 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.
The Audit Lead will ensure that audit processes, systems and procedures, as well auditor competencies align with regulatory expectations and are effective at delivering robust evidence identifying risks and adapting to emerging advances, regulations and industry trends related to the technology / business area, including coaching and developing both RQA and sites-based auditors.
The Audit Lead partners closely with Pfizer Global Supply (PGS) and Pharm Sci teams leading these technologies /business areas to ensure aligned expectations for GMP/GDP requirements and full understanding of Pfizer manufacturing and supply capabilities in these areas.
This position leads independent GMP/GDP audits and inspection preparation activities, resolution of audit and inspection findings, and liaises with appropriate Site Quality and Above Site Quality teams through all stages of the audit lifecycle. The lead partners closely with GMP/GDP Inspection Lead and Planning and Metrics lead to support these activities.
The Audit Lead may lead or participate in complex cross functional projects. This position contributes to enabling a culture of innovation, excellence and continuous improvement of the company’s Quality Management System, through engagement with Pfizer sites to incorporate audit outcomes and best practices across the Pfizer manufacturing and supply network.
The role develops cross functional collaborative relationships to facilitate engagement, team building, best practice sharing, risk-based analysis, critical thinking, and innovative problem solving.
The Audit Lead partners closely with Inspection Lead, Metric and planning Lead and other RQA stakeholders as well as Pfizer PharmSci and PGS teams. The Audit Lead may lead or participate in complex cross-functional projects.
Partner with PGS Operating Units and center functions [e.g Quality Systems and Compliance, Global Technology Engineering + Launch etc] to ensure understanding of new technologies and changes, provide input/review of applicable Rizer requirements + emerging regulations, and identify emerging audit risk areas.
Lead or participate in GMP/GDP assessments (e.g., due diligence, mock inspection, data integrity, quality culture) as required to assess auditee’s Quality compliance:
Here Is What You Need (Basic Qualifications)
Minimum 10 years of progressive, challenging experience in the pharmaceutical, biopharmaceutical and medical device industry required, inclusive of quality control / assurance, manufacturing and GMP/GDP auditing (may include Product Development).
Demonstrated ability to apply the following competencies and soft skills: business skills (negotiation, logical reasoning, critical thinking, decision making, presentation skills); leadership skills (persuasive communication, active listening, active learner); relationship skills (stakeholder management, social perceptiveness, relationship building); and supporting technical skills (technical writing, digital acumen, data analytics). Must understand the elements and requirements of the Quality Management System at the Pfizer facilities, contract manufacturers, suppliers and GMP/GDP service providers audited.
Has a strong understanding of relevant regulatory and audit frameworks that apply to biopharmaceutical and medical device operations, has in-depth knowledge of GMP/GDP requirements and expectations, is familiar with global regulations and internationally recognized standards (e.g., FDA, EU Directive, ICH, TGA, PIC/S, ISO), and is capable of understanding and proactively monitoring emerging regulations and business / regulatory trends.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Bonus Points If You Have (Preferred Requirements)
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Work Location Assignment: Remote
Last Date To Apply: May 6, 2026

The annual base salary for this position ranges from $162,900.00 to $271,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.




Relocation assistance may be available based on business needs and/or eligibility.


Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.


Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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Quality Assurance and Control