Audit Lead

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 as 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 Pharm Sci and PGS teams. The Audit Lead may lead or participate in complex cross-functional projects.

• 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 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 technology advancements.
• Ensure holistic and sustainable action plans to technology portfolio audit outcomes and communication of any new or emerging risks to RQA and PGS / Pharm Sci stakeholders.
• Provide technology portfolio coaching and oversight to RQA and site-based auditors and/or serve as a Subject Matter Expert in the assigned technology area. Review and approve audit reports to ensure alignment and calibration of risk and auditor development.
• 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.
• Develop audit strategy/plans for highly complex audits.
• Acts 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.
• The Audit Lead partners closely with Inspection Lead, Metric and Planning Lead and other RQA stakeholders as well as Pfizer Pharm Sci and PGS teams. The Audit Lead may lead or participate in complex cross-functional projects.
• 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 Standard Operating Procedures.
• Independently plans, leads, and executes 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,…