Manager, External Quality, Contract Testing Organization
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 external quality team. You will provide quality oversight for Pfizer product testing at Contract Testing Organizations (CTOs), including Contract Manufacturing Organizations (CMOs) that perform testing, to ensure compliance with cGMP regulations and quality agreements, including small and large molecules finished intermediates, drug substance, and drug product. You will serve as the quality single point of contact for designated CTOs and participate as a key member of CTO/CMO governance teams to enable site selection and testing implementation - including due diligence activities, oversight of quality activities at testing sites, and/or decommissioning activities. You will also serve as the supplier relationship manager (SRM) for standalone CTOs and oversee governance, quality agreements, contracts, and invoices for the vendor site. You will evaluate and review external QC data for Pfizer’s commercial batch manufacturing 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 testing of products. In the relevant cases, you will coordinate and/or approve investigations and change control activities to ensure compliance with internal processes and regulatory expectations.
As a Manager, you provide guidance to external operational teams for managing projects. Your planning skills will help in preparing forecasts for external resource requirements, and providing areas of improvement for products, processes or services. You will be able to take a leadership role to facilitate agreements between different internal and external stakeholders.
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
Manage activities to support external testing at designated CTOs, including:
Ensure testing is completed and data is provided for review and disposition within timelines specified in quality agreement or testing protocols;
Approve vendor-initiated protocols, procedures, and reports as required;
Coordinate technical changes requested by CTO, including presenting changes to internal change planning committees and other governance teams, perform impact assessments and change approvals;
Perform impact assessments for internally driven method and specification changes to manage site-based implementation of Pfizer changes at CTO;
Drive timely resolution of deviations, testing-related investigations, and CAPAs;
Monitor and report CTO quality performance, drive accountability with CTO on resolution of quality and business performance concerns; troubleshoot and direct the resolution of quality issues, fostering effective interdepartmental and cross-functional partnerships;
Develop, negotiate and maintain Quality Agreements with CTO as required and ensure CTO compliance with agreements;
Ensure CTO maintains analytical methods in a qualified or validated state and in compliance with the regulatory dossier;
Ensure adherence of CTO testing to Pfizer product specifications and coordinate vendor release and stability data review;
Ensure CTO addresses gaps of audit responsiveness and implements effective CAPAs, performs effectiveness checks as required;
Ensures adequate and timely deviation reporting and management, investigation closure, and change management in accordance with the CTO quality agreement and escalate issues with the CTO as appropriate;
Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance; escalate major or critical incidents and appropriate and provide status updates to leadership
10+/8+/6+ years relevant experience in the biotech or pharmaceutical industry and BSc/MSc/PhD or PharmD degree in a relevant field
Prior experience in vendor management for external manufacturing and/or testing
Prior quality control laboratory experience