Manager, GMP Audits

ROLE SUMMARY

• Regulatory Quality Assurance RQA is an independent Quality audit function accountable to identify risks and non-compliance associated with Pfizer's GxP regulated operations. Within RQA, the GMP GDP Audit function is responsible for performing GMP / GDP audits of Pfizer manufacturing and distribution operations, Pfizer license entities, Pfizer country offices, material suppliers, service providers, commercial/clinical manufacturing sites and contract manufacturers that are involved in GMP/ GDP manufacturing, packaging, testing and distribution of APIs, clinical trial materials and commercial biopharmaceutical products worldwide.
• The RQA GMP GDP Audit function is accountable to ensure Pfizer manufacturing and distribution operations are compliant with all applicable global GMP/GDP regulations/standards and Pfizer Quality Standards. The RQA GMP GDP Audit function is required to understand GMP /GDP regulations worldwide and apply this expertise when performing audits, to provide assurance against regulator's interpretation and expectations for compliance with cGMP/GDP requirements.

ROLE RESPONSIBILITIES

• Independently plans/leads/participates in audits of Pfizer manufacturing and distribution operations, Pfizer license entities, Pfizer country offices, material suppliers, service providers, commercial/clinical manufacturing sites and contract manufacturers performing initial and routine audits, managing/leading with minimum oversight
• Leverages responsible use of AI tools to support targeted audit preparation and execution
• May engage with more complex audits including process audits or serve as a reviewer of low complexity, outsourced audits
• Supports and executes on quality programs related to functional areas, specific vendor entities and/or assessments
• Has GMP GDP working knowledge and is called upon to resolve issues based on knowledge of relevant SOPs Standard Operating Procedures, GMP GDP regulations/standards, as well as local regulations and standards
• Works with RQA colleagues on cross GxP audit plans as required
• Ability to manage multiple stakeholders to synthesize feedback and take action with support from Manager

BASIC QUALIFICATIONS

• BS or equivalent, preferably in pharmaceutical or natural sciences, or equivalent
• Extensive expertise in good distribution practices with complex global distribution models, partners and license entities. Knowledge of MAH and WDA regulatory requirements.
• Demonstrates advanced knowledge and understanding of global regulations e.g., FDA, ICH, PIC's, EMA, HC, ANVISA, TGA and international standards e.g., ISO, WHO
• Applies human oversight, professional judgment, and source verification when using AI tools to support audit planning, execution, reporting, and follow-up
• Demonstrates willingness to adopt new audit technologies and contribute to continuous improvement of digital audit workflows and methodologies
• Demonstrates comprehensive working knowledge of business concepts and quality operations
• Ability to think critically to identify and assess areas of greatest risk and develop a strategic approach to audit based on compliance and business knowledge
• Understands quality and auditing frameworks and application
• Exhibits proficient organizational and project management skills
• Demonstrates technical writing skills
• Ability to identify trends within data and apply insights to make recommendations
• Actively identifies areas to assess for greater risk to support senior auditor positions in driving outcomes
• Ability to synthesize information and draw conclusions
• Suggests new audit techniques and approaches, and operationalizes to improve the audit system
• Specializes in at least one conventional technology e.g., API, solid oral dosages

PREFERRED QUALIFICATIONS

• 5-7 years of experience operational or auditing preferredExhibits working knowledge of data analytics and interpretation capabilitiesExpertise in vendor audits plus 1+ technology area MDCP, sterile biologics, small molecules, GDP'sAbility to function autonomouslyin a matrix model and in a team environmentundefined

PHYSICAL/MENTAL REQUIREMENTS

• Primarily a field-based position which includes walking, observing physically and electronically and lifting to assess quality and compliance risks.