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.
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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.
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.