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.  

What You Will Achieve 

How You Will Achieve It  

• 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 / PharmSci 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 PharmSci 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, 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 (e.g., 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. 

Here Is What You Need (Basic 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 required, 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). 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. 

• Critically evaluates information from the auditee and able to identify risk areas in the field. Has the ability to recognize symptoms of problems or situations that require further evaluation and analyze symptoms to determine potential causes and identify possible solutions. 

• Can make both strategic and tactical recommendations and communicate effectively across all leadership levels. Anticipates potential objections and influences others to ensure appropriate outcomes. Takes the initiative and is willing to proactively propose and execute tasks as needed. 

• Can effectively cope with change during an audit. Can lead a diverse audit team and effectively interact with personnel of multicultural backgrounds. 

• Actively leads or participates in cross functional teams for significant and complex projects and contributes 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. 

• 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) 

• Master’s or advanced degree is desirable.  

• Recognized audit certification (e.g., ASQ) is desirable.  

• Experience in site internal audit and shop floor quality assurance is desirable.  

• BoH / Notified Body experience is desirable.  

• Knowledge of Medical Device Regulations is desirable.