External Supply Operations Quality (ESOQ) is responsible for the Quality oversight and management of approximately 400 contract manufacturers, contract testing sites, packagers, suppliers and supply partners globally.As part of the ESOQ Tier 3 structure, QO Lead has responsibility for the effective Quality Assurance Operational Management oversight of Pfizer contractors who manufacture and/or package pharmaceutical products and/or devices on behalf of Pfizer Global Supply. This role is globally focused with partners in multiple geographic locations.The Quality Operations Lead is responsible for assuring product quality of goods or services on behalf of Pfizer and shall have ultimate responsibility for Pfizer lot disposition decisions.Some regional specific roles may have region specific responsibilities.Responsible for:Provide Quality Leadership to support cross functional virtual site operating teams (VSOT) and virtual site leadership teams (VSLT) as appropriate.Successfully lead with strong interpersonal skills to promote the growth and development of manager /senior manager level colleagues. Ensure that colleagues are supported in accordance with Pfizer PEX policies and procedures. Successfully lead the development, implementation and support of Quality Assurance /Quality Control systems for API's, Global Pharmaceutical products, Suppliers and Medical Devices operated by the Contract partner, as applicable.Partner with colleagues to develop and negotiate Quality Agreements.Partner with Global Logistics and Network Services team to ensure GDP oversight is maintained during manufacture and shipping of medicinal product as applicable.Drive the development, implementation and continuous improvement of Pfizer products, processes, and quality systems to ensure Pfizer remains a market leader of Pharmaceutical Product.Proactively support GMP/GDP regulatory inspections at vendors and ensure appropriate Pfizer review/approval of responses to Regulatory Agencies including tracking of Corrective and Preventative actions.Provide Quality Leadership for significant deviations or customer complaints at contractor/partner sites that may impact compliance status or require regulatory notifications. Ensure implementation of effective CAPA and quality system improvements based upon determined remediation activities.Leading generation of QRT summaries as applicable and participating in relevant meetings.Lead quality risk management activities and manage mitigation plans within CMO's / suppliers.Accountable for the on-time disposition of commercial products in line with agreed schedule.Works highly independently, operating with minimal supervision and interacting with all levels of management both at contract partners and within Pfizer.Acts as senior technical/functional expert; provides business direction to site or business group; leverages technical/functional expertise within own business line or sub-function.Demonstrates extensive industry knowledge. Exhibits a high level of business knowledge and understanding of the external marketplace and anticipates business line or sub-function customer requirements.Demonstrates confidence and maturity in operating within a risk-based environment and in compliance with current Good Manufacturing Practices.Develops and leverages resources to implement innovative ideas/processes/ products across business lines or sub-functions.Sets objectives for and manages multiple projects/ ongoing work activities of high complexity within own business line or sub-function.Manages and leads people, technological and financial resources within the business line or sub-function; looking for efficiencies and managing resources outside of direct authority.Develops solutions to complex, ambiguous problems, often outside of own area of expertise and typically as part of a (virtual) team or leadership team. Is accountable for decisions within business line or sub-function.Leverages a variety of communication tools and techniques to help colleagues understand how their work aligns to business priorities.Effectively presents business issues across department or business line.Supporting ESOQ leadership on other tasks as required.If applicable, oversees oversight of external testing activities at CTO for Release and Stability testing. Qualification & SkillsBachelor of Science Degree, Pharmacy, Engineering or other related science degree. Post graduate science-based qualifications preferred.Minimally 10 years' experience in Pharmaceutical or Medical Device Quality Assurance roles with direct responsibility for product quality decisions and /or 15 years' experience in the pharmaceutical or medical device industry.Significant post graduate experience within the pharmaceutical industry with proven success in leading teams and cross functional projects/initiatives. Experience and personal leadership to work in virtual teams preferred.Demonstrated communication and influencing skills to have the ability to interact effectively across all functions and at all levels of an organization, including demonstrating a cultural sensitivity to ensure effective relationships are built and sustained.Experience with managing external suppliers/contractors, preferred.Demonstrated experience in effectively managing a team.Demonstrated ability to manage complex quality and compliance activities related to pharmaceutical products at a manufacturing plant or with a contractor.Demonstrated investigation skills and knowledge of DMAIC, 6sigma, YB or GBAbility to effectively manage multiple projects, prioritize work for self and others and accomplish tasks through effective teamwork.Demonstrated ability to resolve conflictsAdvanced computer skills for MSOffice and enterprise systems such SAP, QTS/QMS, Vault, PDM, Documentum platforms, Minitab and AI tools such as CoPilotProficient in English (written and spoken)Strong technical writing skillsStrong verbal, written communication, and presentation skillsDemonstrated DEI attitudeDemonstrated clinical and specials license know howDemonstrated experience managing batch certification and importationTakes initiatives and is proactive, persistentStrong organizing and planning skills and a high sense of urgency.Have a detailed knowledge of the manufacture and packaging (primary and secondary) of drug substance manufacturing, solid oral dose pharmaceuticals and/or Aseptic / Sterile pharmaceutical products.Possess an in-depth knowledge of quality system regulations including a demonstrated ability to evaluate and apply global GMPs to build effective Manufacturing/QA/QC systems.Possess knowledge of main regulatory directives and guidelines (dossier structure, variation guideline)Resources Managed: Budget & FTEs5-9 direct reportsFinancial Accountability - Accountable for reviewing and approving colleague expenses and for ensuring costs are managed within budget expectations.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSUp to 20% travelWork Location Assignment: Flexible (global, site or remote based)ORGANIZATIONAL RELATIONSHIPSInteract with QSEO functions such as SOQ, SBO, SMO (Including RPs), Compliance Team and RQAExternal Supply Community - External Supply (ES), Global Supply Chain (GSC), and Global Technology Engineering & Launch (GTEL) and GLNS (Global Logistics & Network Services)VSLT (Virtual Site Leadership Team) and VSOT (Virtual Site Operating Team)Pfizer partner groups within Center QO/EHS, ES, Regulatory, GSC, CoE, GTEL, SME, Procurement, Product Portfolio Leads & Operational ExcellenceInteract with Quality Functions of CMO and external partners to discuss Quality Agreement, Quality Improvement and Quality escalation topics.Work Location Assignment: HybridClosing Date: 9 January 2026
Additional Information In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland. Please note there is no relocation support available for this position
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Purpose
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