External Supply Operations Quality (ESOQ Manager) Role Description: The Global External Quality Operations Mission is to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives. External Supply Operations Quality (ESOQ) is committed to supporting Pfizer Global Supply (PGS) as an innovative and competitive advantage for Pfizer by assuring the quality of products manufactured and packaged by other companies (Contractors) for Pfizer. ESOQ is responsible for the Quality & Regulatory management of approximately 300 contract manufacturers, packagers, and supply partners globally. Responsibilities: The ESOQ Manager is accountable for providing quality assurance management of key contractors for Pfizer and for assuring that the products supplied to our patients are manufactured & tested in accordance with c-GMPs, the registration file and any additional country specific requirements. This is highly independent position operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within Pfizer. The ESOQ Manager will operate as spokesperson for ESOQ and will focus on developing relationships, independently negotiating, developing and communicating Pfizer quality requirements with contract manufacturers. The ESOQ Manager will have significant interactions with many internal business and manufacturing organizations (e.g. External Supply, Regulatory, Technical Support, Quality, PGS sites and R&D) and will lead virtually-based cross functional teams. Initiate, review and approve regulatory changes through Pfizer enterprise system (i.e PDM) for changes initiated by or impacting ESOQ managed contractors. Provide support for the closure of the deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations. Main point of contact for Global Chemistry Manufacturing & Controls (GCMC) dpt or Local Regulatory Affairs in Pfizer Country Offices (Single market prods) for the regulatory activities involving the ESOQ contractors. As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meeting for ESOQ managed contractors and if needed, participate in Site Quality visits at the contractors. Support and Perform Lot Disposition for Biotech semi finished and finished products (if applicable). Qualifications: Minimally BA/BS Science, Engineering, or related technical discipline with strong experience in a GXP setting and/or Regulatory Affairs role. Some experience in Product Quality Assurance experience in a GMP environment. Aseptic manufacturing experience would be an asset. Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, PDM, Documentum platforms. Command of English language required and multi-lingual is a benefit. Strong verbal and written communication including presentation skills. Shows strong negotiation skills and is diplomatic in communication with internal and external customers. Demonstrated ability to manage multiple projects and priorities. Demonstrated ability to prioritize work, to act and work independently and to report items as required to Team leader. Demonstrated excellent organization skills. Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor. Developing personal leadership to manage cross functional projects. Developing ability to resolve conflicts. Takes initiatives and is proactive, persistent. Has a broad GMP and technical know-how to handle emerging issues. Able to deliver work independently. Up to 20% travel may be required. Work Location Assignment: Hybrid (some office presence is required) Purpose Breakthroughs that change patients' lives At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation! Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. DisAbility Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here! Quality Assurance and Control