Manager, External Quality
Vor 5 Tagen
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective Quality Assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
It is your problem solving skills that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It- Serve as Quality Single Point of Contact on one or more internal Virtual Management Teams consisting of External Manufacturing Operations, Quality, Supply Chain, Technical Development or Manufacturing Sciences & Technology representatives.- Develop, negotiate and maintain Quality Agreements with CMOs and ensure compliance with agreements.- Manage all required activities to support production including approval of master production documentation, resolution of investigations, assessment of change controls, and monitor and report CMOs quality performance.- Perform Technical Disposition of clinical/commercial products.- Hold the CMOs accountable for maintaining the manufacturing processes and the Specifications and Analytical Methods in a validated state and compliant with the regulatory dossier.- Oversee complex investigations in partnership with CMOs and report to Pfizer’S Material Review Board and CMC teams.- Develop/maintain quality risk management plans; utilize risk management tools to identify and mitigate CMO quality and compliance risks, ensuring CMO sites are in a state of continuous inspection readiness.- Accountable for inspection readiness of the CMOs. Provide as needed support during regulatory inspections and cGMP compliance audits, collaborating with CMOs to ensure on time closure of associated CAPAs as needed.- Ensure that CMOs provides Annual Product Quality Reviews, product complaint investigations and other quality GMP documents in a timely manner following expectations set forth in the Quality Agreement.- Hold the CMOs accountable and address gaps of Pfizer audit responsiveness, CAPA implementation, deviation reporting and management, investigation closure, and change implementation with regards to quality and time with the CMO; and escalate as appropriate.- Lead investigation at the CMO with Pfizer cross-functional team support.- Support internal teams to get documentation while preparing regulatory dossiers.- Monitor and assess External Suppliers’ key performance indicators to propose Continuous Improvement initiatives.- Develop/maintain quality risk management plans; utilize risk management tools to identify and mitigate CMO quality and compliance risks, ensuring CMO sites are in a state of continuous inspection readiness.- Collaborate and manage relationships across CMO management and internal governance teams to assure quality expectations are aligned and support joint improvement goals.- Notify Senior Management of potential quality or regulatory issues that may impact compliance.- Sign documents as authorized and described by Pfizer policies, procedures and job descriptions.- Review and approve process validation protocols and reports- Maintain and communicate work priorities to meet goals and timelines.- Support investigations connected with Product Complaints and Recalls/Mock Recalls.- Complete all job-related training while striving to continuously improve on knowledge and skills in quality, compliance and technology.- Communicate new and updated regulatory requirements and applicable Pfizer expectations to CMO, as applicable, and evaluate systems in place.- Ensure that CMOs make available data for process monitoring purpose as requirement for the CPV activities at Pfizer.
**Qualifications**:
Must-Have- Bachelor's Degree/Master's degree- Minimum of Bachelor’s degree in a scientific discipline (Pharmacy, Chemistry, Microbiology, etc.) and 12+ years of experience in the pharmaceutical industry / Master's Degree and 8+ years of experience in the pharmaceutical industry- Ability to travel domestically and internationally 20% of time- 8/12+ years relevant GMP Experience- Pharmaceutical manufacturing/Quality experience- Current Good Manufacturing Practices experience with compliance issues resulting from cG
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