Lkw450 Regulatory Quality Assurance Gmp Audit Manager

.ROLE SUMMARY As assigned, independently lead or participate in GMP/GDP audits and assessments of contract manufacturers, suppliers and GMP/GDP service providers involved in the manufacture, packaging, testing and distribution of APIs, clinical trial materials and commercial biopharmaceutical products worldwide. Assess if the auditee is executing operations in compliance with cGMP/GDP requirements and guidelines, Pfizer Quality Standards and Quality Agreement requirements and Standard Operating Procedures. Assess whether employees are being properly trained for their responsibilities, as well as the adequacy of the facilities and equipment used for manufacturing, packaging, testing and distribution of APIs, clinical trial materials and commercial biopharmaceutical products. Communicate relevant quality and business information to the contract manufacturer, supplier or GMP/GDP service provider audited, in an effort to maintain and enhance the relationship between the auditee and Pfizer. Interpret regulatory and business challenges and best practices, report risks or weaknesses that could lead to cGMP/GDP compliance issues, and recommend improvements or solutions. Lead or participate in GMP audits at contract manufacturers, suppliers and GMP/GDP service providers. May participate in GMP audits of Pfizer facilities. Responsibilities for these activities include but are not limited to:Lead negotiations with auditees to schedule auditsLead audit preparation activities including gathering of and review of auditee' relevant quality and performance metrics to determine risk-based audit scopeLead the audit execution, or actively participate in the audit execution as directed by the lead auditorLead the preparation of audit reportsLead the review and evaluate the adequacy of the auditee response to audit findingsPerform audit follow-up activities as required or as directed by leadershipDevelop cross functional collaborative relationships to facilitate engagement, team building, best practice sharing, risk-based analysis, critical thinking and innovative problem solving. Participate in department wide initiatives to advance the business strategy of the GMP audit function