Manager, External Quality Operations

Use Your Power for Purpose

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those who rely on our products.

What You Will Achieve

In this role, you will : Manage all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers that supply materials / product(s) to Pfizer according to established procedures.

• Assess the quality of external supplier's products, processes and related documents while ensuring the product specifications are met and quality systems are maintained.
• Support internal and external partners with auditing activities related to ESOQ activities, or activities at a portfolio of contractors - (RQA audits or regulatory inspections) as applicable.
• Support internal and external partners with Compliance Assessments to ensure current GMP / GDP adherence.
• Manage Risk at Vendors implementing Quality Improvement Plans and support Risk assessments, QRTs and QANs as necessary.
• Support onboarding activities of new CMO's or product launches within the portfolio as applicable.
• Support offboarding activities for exiting CMO's / products / SKUs within the portfolio as applicable.
• Make product Quality decisions leveraging comprehensive knowledge of Quality / Manufacturing principles, prior work experience and concepts in other technical areas while ensuring compliance to global regulatory and Pfizer requirements.
• Influence quality decision making in line with industry and Pfizer requirements.
• Provide Quality Leadership within the cross functional virtual site operating teams (VSOT).
• Partner with colleagues to develop and negotiate quality agreements.
• Review and approve Annual Product Review and Product Quality Review (APR / PQR) reports and relevant product stability reports.
• Perform batch disposition endorsement.
• May Identify, develop and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with the latest internal and external standards.
• Ensure the adequate tracking and documentation of all required quality related actions in the relevant system(s) and that all required escalation processes are followed.
• Lead and support complex investigations, market complaints, risk assessments in support of products within your portfolio. Raise NTMs and connect with SMEs where needed.
• Support Global Logistics and Network Services team to ensure GDP oversight is maintained during manufacture and shipping of medicinal product.
• Provide Performance Metrics for key performance indicators.
• Work independently, receive instructions primarily on unusual or complex problems.
• Build, maintain and develop relationships with key stakeholders, both internal and external to Pfizer.
• Support ESOQ leadership in other tasks as required.

Here Is What You Need (Minimum Requirements)

Bonus Points If You Have (Preferred Requirements)

Physical / Mental Requirements

The position requires office job involving use of computer and to collaborate with stakeholders based in different locations and time zones.

Non-Standard Work Schedule, Travel or Environment Requirements

Up to 20% travel at CMO premises can be required. Work Location Assignment : On Premise