CMC Manager (m/f/d)

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.

What You’ll Do

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.

Key Responsibilities

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 

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 Inclusion

Our 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!

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Quality Assurance and Control