Manager, GMP Audits

Pfizer South Africa's vision of "living our full potential in striving for a healthier Southern Africa" forms part of Pfizer's ethos whereby every Southern African should have access to quality healthcare. At Pfizer South Africa we are dedicated to the improvement of human life and the battle against disease & disability. We have a leading portfolio of products and medicines that support wellness and prevention, as well as treatment and cures for diseases across a broad range of therapeutic areas. Pfizer is considered one of the largest research-based pharmaceutical companies. Through our people; our research; our knowledge; our products and our community partnerships, we seek to save, prolong and enhance the lives of South Africans. In addition, setting the standard for quality, safety and value in terms of research, development and manufacture of medicines for humans is key. Bio-pharmaceutical Pfizer South Africa's biopharmaceutical division is part of a globally-renowned Pfizer Inc., the world's largest research-based pharmaceutical company whose history dates back to the 1880s. Pfizer's vast product range covers a variety of sectors, including oncology, vaccines, cardiovascular, biological medicine, neuroscience, urology, anti-inflammatory, anticoagulation, anti-infectives, pain medication and ophthalmology. Stakeholders include healthcare professionals, patient groups, pharmacy groups, hospital groups, media and government. The company currently boasts a total workforce of just over 310 employees, and is rated among the Top Five American employers in the country and continues to achieve accolades in its quest to lead the field in the improvement of human life and the battle against disease and disability.

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.