CMC Manager (m/f/d)

CMC Manager (m/f/d) – QA Compliance, Pfizer SträngnäsBreakthroughs that change patients’ livesAt Pfizer, we are a patient-centric company guided by our four values: courage, joy, equity and excellence. Our breakthrough culture reflects our commitment to science, quality and improving patients’ lives around the world.You will join a collaborative environment with strong global connections, where continuous improvement, knowledge sharing, and cross-functional teamwork are central to how we work.About the SitePfizer Strängnäs is one of Sweden’s largest biotech manufacturing sites for commercial production of pharmaceutical active substances. With a strong culture of continuous improvement, Six Sigma and Lean, our multi-product facility plays an important role in delivering high-quality products to patients worldwide. We are currently facing exciting opportunities to introduce new technology and further strengthen our operations.What You’ll DoWe are looking for a CMC Manager within QA Compliance. In this role, you will serve as a key link between the Strängnäs site and Pfizer Global CMC, helping to ensure that regulatory requirements are understood, implemented, and maintained across the site.You will be responsible for managing regulatory aspects of marketed drug substances, including CMC documentation, regulatory changes, and interactions with global stakeholders and health authorities.Key ResponsibilitiesIn this role, you will:Serve as the site interface to Global CMC and represent the site in relevant global networks and forumsLead and coordinate the preparation, compilation, and maintenance of CMC documentationAssess the regulatory impact of proposed changes and support the regulatory strategy for site changesCoordinate regulatory change management activities, including preparation of supporting documentation and tracking of change status across systemsSupport responses to health authority questions, inspections, and regulatory commitmentsCollaborate closely with cross-functional teams, including Product Teams, Tech Teams, subject matter experts, and global stakeholdersMonitor regulatory status, commitments, and approvals, and communicate relevant updates across the siteContribute to Annual Product Reviews and ensure regulatory documentation is available to support site needsProvide guidance and training on regulatory and CMC-related topics within QA and across the siteSupport inspections and act as a key contact for regulatory topics when neededWhat You BringWe are looking for someone who brings:A university degree in a scientific discipline, such as pharmacy, chemistry, biotechnology, or a related fieldSolid experience in the pharmaceutical industry, including GMP and quality systemsExperience working with regulatory and CMC-related topics for marketed productsExperience working in global, cross-functional environmentsA strong understanding of cGMP and regulatory requirementsExcellent communication and collaboration skillsThe ability to work independently and manage multiple prioritiesFluency in both written and spoken English and SwedishWhy Join Pfizer SträngnäsAt Pfizer Strängnäs, you will have the opportunity to:Be part of a global organization with strong expertise and collaboration across sitesWork in a role with a meaningful impact on regulatory compliance and product qualityHave opportunities for development within Quality, Regulatory, and global networksContribute to a culture of continuous improvement and innovationWork Location Assignment: Onsite, Strängnäs, SwedenDiversity, Equity & InclusionAt Pfizer, we are committed to creating an inclusive workplace where diverse perspectives are valued. We welcome applicants from all backgrounds and ensure a fair and equitable recruitment process for everyone.   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 InclusionOur mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here! Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers. Quality Assurance and Control