CMC Manager (m/f/d)

Responsibilities

• We 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.
• In this role, you will:
• Serve as the site interface to Global CMC and represent the site in relevant global networks and forums
• Lead and coordinate the preparation, compilation, and maintenance of CMC documentation
• Assess the regulatory impact of proposed changes and support the regulatory strategy for site changes
• Coordinate regulatory change management activities, including preparation of supporting documentation and tracking of change status across systems
• Support responses to health authority questions, inspections, and regulatory commitments
• Collaborate closely with cross-functional teams, including Product Teams, Tech Teams, subject matter experts, and global stakeholders
• Monitor regulatory status, commitments, and approvals, and communicate relevant updates across the site
• Contribute to Annual Product Reviews and ensure regulatory documentation is available to support site needs
• Provide guidance and training on regulatory and CMC-related topics within QA and across the site
• Support inspections and act as a key contact for regulatory topics when needed
• What You Bring
• We are looking for someone who brings:
• A university degree in a scientific discipline, such as pharmacy, chemistry, biotechnology, or a related field
• Solid experience in the pharmaceutical industry, including GMP and quality systems
• Experience working with regulatory and CMC-related topics for marketed products
• Experience working in global, cross-functional environments
• A strong understanding of cGMP and regulatory requirements
• Excellent communication and collaboration skills
• The ability to work independently and manage multiple priorities
• Fluency in both written and spoken English and Swedish
• Why Join Pfizer Strängnäs
• At Pfizer Strängnäs, you will have the opportunity to:
• Be part of a global organization with strong expertise and collaboration across sites
• Work in a role with a meaningful impact on regulatory compliance and product quality
• Have opportunities for development within Quality, Regulatory, and global networks
• Contribute to a culture of continuous improvement and innovation
• Work Location Assignment: Onsite, Strängnäs, Sweden
• Diversity, Equity & Inclusion
• At 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
• Disability Inclusion

Benefits

Additional Information

CMC Manager (m/f/d) - QA Compliance, Pfizer Strängnäs 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 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 Site Pfizer 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.

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