Manager, External Quality Operations
Pfizer
full-time
Posted on:
Location Type: Office
Location: Pearl River • Florida, Illinois, New York, North Carolina, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $96,300 - $160,500 per year
Job Level
SeniorLead
Tech Stack
Vault
About the role
- 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 ensuring product specifications are met and quality systems are maintained
- Support internal and external partners with auditing activities related to ESOQ activities, RQA audits or regulatory inspections
- 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 and offboarding activities for exiting CMO’s/products/SKUs within the portfolio as applicable
- Make product Quality decisions leveraging comprehensive knowledge of Quality/Manufacturing principles
- Influence quality decision making and provide Quality Leadership within 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
- Identify, develop and implement continuous improvement initiatives related to ESOQ processes
- Ensure adequate tracking and documentation of all required quality related actions and follow escalation processes
- Lead and support complex investigations, market complaints, risk assessments and raise NTMs connecting with SMEs where needed
- Support Global Logistics and Network Services team to ensure GDP oversight during manufacture and shipping of medicinal product
- Provide Performance Metrics for key performance indicators
- Build, maintain and develop relationships with key stakeholders and support ESOQ leadership in other tasks as required
Requirements
- Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an associate's 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
- Demonstrated managerial/organizational skills; takes initiative and is proactive
- 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)
- Experience on managing investigations (DMAIC, 6sigma, ...)
- Demonstrates the ability to influence and collaborate with peers
- Requires permanent work authorization in the United States
- Up to 20% travel to CMO premises may be required
- PHYSICAL/MENTAL REQUIREMENTS: office job involving use of computer and collaboration with stakeholders in different locations/time zones
- Bonus/Preferred: A solid understanding of device and combination product industry regulations; Strong analytical and problem-solving skills; Experience in interfacing with regulatory agencies during audits; Ability to drive continuous improvement initiatives
Benefits
- Participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary
- Eligibility to participate in Pfizer’s share based long term incentive program
- 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage
- Comprehensive and generous benefits and programs
- Relocation assistance may be available based on business needs and/or eligibility
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality managementcompliance assessmentrisk assessmentcontinuous improvementtechnical writingpharmaceutical manufacturingDMAIC6sigmaGMPGDP
Soft skills
leadershipcommunicationorganizational skillsinitiativeplanningcollaborationproblem-solvinginfluencepresentation skillsindependence