Audit Lead

Job description

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 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...