Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or research analysis, your contributions are vital and directly impact patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. As the Director of Quality Assurance within the Global Supply division, you will play a pivotal role in improving patients' lives by ensuring the highest standards of quality and safety in our products. Your leadership and expertise will drive the growth of our Quality Assurance team, fostering a culture of innovation and excellence that directly impacts the well-being of patients worldwide. What You Will Achieve In this role, you will: The role has responsibility for the leadership of the development team, oversight and delivery of the Medical Device and Combination Products (MDCP) portfolio in partnership with Pharmaceutical Sciences (BTx and PSSM organizations). You will work closely with cross-functional teams to establish innovative methodologies, facilitate agreements, and rigorously review deliverables to guarantee product safety, compliance, and efficacy. Your specialized knowledge will contribute to achieving global/team goals within Pfizer’s quality system, necessitating exceptional communication, analytical, and consensus-building abilities. This role requires a self-motivated professional who can proactively identify and address issues, communicate across all organizational levels, prioritize quality, assist in completing critical deliverables, clarify complex matters, and foster effective teamwork. Act as the MDCP QA lead for product development supporting Cambridge (Devices Centre of Excellence), Andover/St Louis (Drug Product Design and Development) and Groton ensuring QMS execution and continuous improvement Provide supervision and technical mentorship to MDCP QO colleagues supporting product development within Pharmaceutical Sciences Ensures policies and procedures for assuring that the quality assurance and compliance requirements of the company are met Provide Quality Assurance support and direction to Pharmaceutical Sciences project teams accountable for MDCP projects Ensure device design and development, and device/vaccine product development meets appropriate regulatory requirements by providing pro-active guidance through all stages of development in accordance with 21 CFR 820, ISO 13485, IEC 62366, IEC62304 and MDCP procedures Partner with Pharm Sci/GTEL device personnel and project team, as required, in the resolution of Medical Device Corrective Action and Preventive Action ( CAPA) and complaints. Lead and ensure risk management activities are developed in accordance with ISO 14971 and MDCP procedures. Provide device design and development quality expertise to Pfizer Global Supply (PGS) sites and device contractors as required. Provide device expertise to PGS audits of external contractors involved in device development and manufacture. Responsible for communication and escalation of MDCP quality issues within Pfizer QA oversight of facility, utilities, equipment, computer system validations and change controls Leads/Support Management Review & Quality Councils Responsible for working with Pharmaceutical Sciences and managing all Quality and compliance aspects of external contractor activities & oversee GMP work placed with the contractor related to medical device/combination products to ensure consistency and compliance with regulatory expectations and company standards Provide Quality Assurance as required for s ustaining/maintaining the MDCP portfolio by Global Technical Engineering & Launch, Parsippany US Responsible for maintenance of the PS Vendor management quality system for assigned MDCP vendors Recognized as a coach, mentor, and technical expert; participates as an external influencer at conferences or standard committees. Evaluates highly complex quality issues on projects or with vendors and provides suggested issue resolutions. Responsible for communication and escalation of vendor-related quality issues within Pfizer: Maintain close working relationship with Pharmaceutical Sciences, Legal Manufacturers and other QA lines. Lead and support investigations of significant quality and/or regulatory events associated with external suppliers Here Is What You Need (Minimum Requirements) BA/BS with at least 8 years of experience or MBA/MS with at least 7 years of experience or PhD/JD with at least 5 years of experience or MD/DVM with at least 4 years of experience Proven technical knowledge and expertise in root cause analysis (RCA) and CAPA activities Demonstrated in-depth understanding of global regulations, guidelines, and evolving legislation Excellent organizational, analytical, strategic, interpersonal, written, and oral communication skills Thorough understanding and application of cGMP principles, relevant quality processes, systems, and Country Specific Standards Experience in developing and leading complex projects and mid-term plans Ability to make decisions in complex problems and identify innovative solutions Thorough understanding and application of one of the following: 1) cGMP and current good manufacturing practices in a pharmaceutical environment, 2) 21 CFR 820, Rule 21 CFR “4” current good manufacturing requirements for Combination Products, or 3) medical devices and/or combination products including ISO 13485 & ISO 14971 Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgement Strong leadership, negotiation, interpersonal, communication, and facilitation skills Strong analytical and computer skills are required. Thorough understanding and application of cGMP specifically 21 CFR 820, Rule 21 CFR Part “4” current good manufacturing requirements for Combination Products and the principles and concepts of relevant quality processes and systems. Thorough understanding and application of EU ISO Standards specifically ISO 13485 & ISO 14971 at a minimum. Extensive experience working in a Quality Assurance, GMP manufacturing or Medical Device role. Experience in complaint investigations of medical devices related to design. Experience interacting with FDA investigators and other regulatory agencies audits. Bonus Points If You Have (Preferred Requirements) Master’s degree coupled with significant pharmaceutical experience. Proficiency in engaging with FDA, EU investigators, and other regulatory bodies during audits Profound grasp of compliance and quality management, including the necessary procedures and audit readiness requirements Extensive experience within regulated environments, encompassing policies, procedures, and processes Strong leadership and team-building skills Ability to influence and partner with cross-functional leadership Excellent problem-solving and decision-making abilities Strong project management skills Ability to foster a culture of innovation and continuous improvement Ability to lead and deliver in a matrix environment ISO 13485 Lead Auditor Certification ASQ CQE Certification (optional) Work Location Assignment: Hybrid 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