Audit Lead

Responsibilities

• Lead strategy, delivery, and maintenance audits for technology or business.
• Area of focus: Aseptic/Sterile/Biologics/Biotechnology.
• Develop and implement technology / business focused audit strategy to ensure procedures and guidelines remain aligned with applicable regulations and remain current and are effective at enabling identification of emerging risks.
• Ensure understanding and working knowledge of all applicable regulations and emerging regulatory trends for the associated technology area.
• Analyze regulatory intelligence, including emerging regulations and audit and inspection outcomes in the assigned technology portfolio to ensure audit focus areas remain relevant to emerging regulations and technological advancements.
• Ensure holistic and sustainable action plans to technology portfolio audit outcomes and communicate any new or emerging risks to RQA and PGS / PharmSci stakeholders.
• Provide technology portfolio coaching and oversight to RQA and site-based auditors and/or serve as a subject matter expert; review and approve audit reports to ensure alignment and calibration of risk and auditor development.
• Partner with PGS operating units and center functions to ensure understanding of new technologies and changes, provide input/review of applicable Rizer requirements and emerging regulations, and identify emerging audit risk areas.
• Develop audit strategy/plans for highly complex audits.
• Act as a leader in RQA by continuously improving audit practices, sharing knowledge with peers and stakeholders and ensuring RQA and site-based auditors are adequately skilled and trained to meet the needs of the business and the audit function.
• Represent GMP/GDP audit and participate in industry forums in the assigned technology portfolio.
• Lead or participate in RQA or PGS initiatives to advance the strategy of the audit function.
• Lead or participate in GMP/GDP audits at Pfizer facilities, contract manufacturers, suppliers, and process audits (as applicable).
• Assess if the auditee is executing operations in compliance with GMP/GDP requirements, guidelines, Pfizer standards and quality agreement requirements and SOPs.
• Independently plan, lead, and execute the audit strategy for complex process audits.
• Interpret regulatory and business challenges and best practices, report risks or weaknesses that could lead to GMP/GDP compliance issues and recommend required improvements or solutions.
• Maintain and expand current knowledge of applicable regulations, guidelines, internationally recognized standards and Pfizer standards that could impact the auditee’s operations.
• Liaise between the auditee and the appropriate Pfizer groups to ensure that all pertinent information that could have an impact on the auditee’s or Pfizer’s business are assessed as part of the audit strategy.
• Lead or participate in GMP/GDP assessments such as due diligence, mock inspection, data integrity, quality culture as required to assess auditee’s quality compliance.
• Aid the auditee in preparing for upcoming regulatory inspections.
• Apply technology knowledge to influence the design, planning and execution of cross‑functional projects.
• Collaborate proactively with RQA and site leadership and subject‑matter experts to enable a culture of excellence in the execution of independent objective audits and evaluation of effective CAPAs.

Qualifications

• Bachelor’s degree in pharmaceutical sciences or equivalent required.
• Minimum 10 years of progressive, challenging experience in the pharmaceutical, biopharmaceutical and medical device industry, inclusive of quality control/assurance, manufacturing and GMP/GDP auditing (may include product development).
• Aseptic manufacturing experience and/or expertise required.
• Proven knowledge and experience in GMP/GDP auditing of at least 3 technology areas.
• 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).
• Strong understanding of relevant regulatory and audit frameworks that apply to biopharmaceutical and medical device operations, in‑depth knowledge of GMP/GDP requirements and expectations, familiarity with global regulations and internationally recognized standards (FDA, EU Directive, ICH, TGA, PIC/S, ISO) and ability to proactively monitor emerging regulations and business/regulatory trends.
• Critical evaluation of information from the auditee and ability to identify risk areas; recognize symptoms, analyze causes and propose solutions.
• Effective strategic and tactical recommendation and communication across all leadership levels; anticipate objections and influence others to achieve appropriate outcomes.
• Ability to cope with change during an audit; lead a diverse audit team and interact with personnel of multicultural backgrounds.
• Actively lead or participate in cross‑functional teams for significant and complex projects, contributing towards outcomes that promote innovation and excellence.
• Ability to work independently and lead or participate in global audit teams and effectively communicate to peers and leadership inside and outside the company.
• Ability to conduct ad hoc GMP/GDP assessments as required to support business needs.
• Broad leadership experience and capabilities, including influencing and collaborating with peers, developing and coaching others, and overseeing work that drives meaningful outcomes and business impact.

Preferred Qualifications

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

Work Requirements

• Travel required: ability to travel up to 40% of the time, including domestic and international travel.
• Remote work location assignment.
• Reports to GMP/GDP Audit Team Lead.

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.