Manager, Gmp Audits
full-time
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 preferred)Exhibits working knowledge of data analytics and interpretation capabilitiesExpertise in vendor audits plus 1+ technology area (MDCP, sterile biologics, small molecules, GDP's)Ability 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.