Manager - External Supply Operation Quality

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About the role

ROLE DESCRIPTION   ·        Role and Accountabilities Actively contributes as part of the ESOQ Tier 2 structure to ensure that Pfizer's network of external suppliers, CMOs, and partners are supported to deliver high quality products, on time, and in compliance with all established standards, agency guidelines, and applicable GMP/GDP regulations.   • Responsibilities o   Manage all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers that supply materials/products to Pfizer according to established procedures. o   Assess the quality of external suppliers' products, processes, and related documents while ensuring product specifications are met and quality systems are maintained. o   Support internal and external partners with auditing activities related to ESOQ activities or contractor portfolios (RQA audits or regulatory inspections). o   Support internal and external partners with Compliance Assessments to ensure current GMP/GDP adherence. o   Manage vendor risk, implementing Quality Improvement Plans and supporting Risk Assessments, QRTs and QANs. o   Support onboarding of new CMOs and product launches. o   Support offboarding activities for exiting CMOs, products, and SKUs. o   Make product quality decisions leveraging quality and manufacturing expertise while ensuring compliance with regulatory and Pfizer requirements. o   Influence quality decision making in line with industry and Pfizer requirements. o   Provide Quality Leadership within Virtual Site Operating Teams (VSOT). o   Partner with colleagues to develop and negotiate Quality Agreements. o   Review and approve Annual Product Reviews (APR), Product Quality Reviews (PQR), and stability reports. o   Perform batch disposition endorsement.   • Additional Responsibilities o   Identify, develop, and implement continuous improvement initiatives related to ESOQ processes. o   Ensure tracking and documentation of quality-related actions and escalation processes. o   Lead and support investigations, market complaints, risk assessments, and Management Notifications (MN). o   Provide performance metrics and KPI reporting. o   Work independently and handle unusual or complex problems. o   Build and maintain relationships with internal and external stakeholders. o   Support ESOQ leadership as required.   • If applicable o   Manage quality/compliance activities for CMOs, and suppliers. o   Ensure stability studies at CMO/CTO sites are conducted according to approved protocols and ICH guidance.   QUALIFICATIONS / SKILLS • Education o   Bachelor of Science degree (minimum), Pharmacy, Engineering, or related technical discipline. • Experience o   10 years' experience in the pharmaceutical industry with minimum 5 years hands-on sterile experience in Production and/or Quality Assurance. o   Experience in pharmaceutical manufacturing including: API/DS and Drug Product (DP).   • Skills o   Experience with external suppliers/contractors. o   Advanced computer skills in: MS Office, SAP, QTS, Veeva Vault o   Proficient in English and technical writing. o   Strong verbal, written communication, and presentation skills. o   Demonstrated leadership in virtual teams and cross-functional initiatives. o   Experience managing complex quality and compliance activities. o   Strong problem-solving and innovation mindset. o   Demonstrated managerial and organizational skills. o   Proactive and persistent. o   Strong planning and organizational capabilities. o   Ability to work independently and appropriately escalate issues. o   Knowledge of US, EU, and global cGxP regulations and inspection trends. o   Proven leadership and facilitation skills. o   Ability to influence and collaborate effectively with peers.   NON-STANDARD WORK SCH

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