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 suppliers 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 CMOs or product launches within the portfolio as applicable.

• Support offboarding activities for exiting CMOs/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)

• Applicant must have a bachelors degree with at least 4 years of experience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR as associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience

• Experience with external suppliers/contractors.

• Advanced computer skills for MSOffice and enterprise systems such SAP QTS Vault Documentum platforms Minitab

• Proficient in English and technical writing

• Strong verbal written communication and presentation skills

• Demonstrated personal leadership to work in virtual teams and cross functional projects/initiatives

• Demonstrated experience managing complex quality and compliance activities

• Problem solving attitude and open to innovation

• Demonstrated managerial/organizational skills

• Takes initiatives and is proactive persistent

• Good organizing and planning skills and a high sense of urgency

• Demonstrated ability to act and work independently and to report items as required to line manager

• Demonstrated knowledge of US European and global cGMPs compliance issues inspectional trends industry quality assurance practices

• Demonstrated technical know how

• Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives

• Demonstrated experience in pharmaceutical manufacturing activities (API DP Biotech Oral Solid Dosage Aseptic) applicable to the role

• Experience on managing investigations (DMAIC 6sigma ...)

• Demonstrates the ability to influence and collaborate with peers
  
  
  Bonus Points If You Have (Preferred Requirements)

• A solid understanding of device and combination product industry regulations

• Strong analytical and problem-solving skills

• Ability to work independently and make decisions

• Excellent organizational and time management skills

• Experience in interfacing with regulatory agencies during audits

• Ability to drive continuous improvement initiatives
  
  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% travelat CMO premises can be required.

Relocation assistance may be available based on business needs and/or eligibility.