Manager MFG Process Compliance & Documentation

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Are you passionate about people development and experienced in leading organizational transformation in strategy, operations, and culture? Do you excel at creating direction through process standardization and optimization?

At AGC Biologics, we are looking for a motivated manager to lead our Manufacturing (MFG) Process Compliance & Documentation team. This position is a maternity cover for a period of 1 year.

About the Role
As the Manager of MFG Process Compliance & Documentation, you will lead a team of specialists focused on enhancing and streamlining manufacturing processes. Your team’s mission is to optimize and standardize operations, ensuring smooth and compliant workflows throughout the organization. Key responsibilities include:

• Creating and providing essential tools such as templates, standardized workflows, and high-level procedures to guide manufacturing teams.
• Ensuring inspection readiness by maintaining up-to-date documentation, compliant systems, and tools.
• Identifying opportunities for continuous improvement through data analysis and driving innovations that enhance performance.

You will play a pivotal role in keeping processes compliant, efficient, and always ready for internal and external audits, while fostering a culture of ongoing improvement across the team.

You and your team will collaborate closely with the Training Readiness & Support team, project managers, and various manufacturing teams. You will report directly to the Director of Manufacturing Readiness & Compliance.

Key Responsibilities

• Lead, motivate, and coach your team, setting a clear direction and fostering a high-performance culture.
• Build strong collaboration across teams, particularly with other areas of Manufacturing, QA, QS, and key stakeholders.
• Take ownership of projects related to templates, standardized processes, and high-level procedures.
• Ensure all activities are aligned with Manufacturing goals and operational requirements.
• Recruit and onboard new team members, fostering a supportive and engaging environment.

Qualifications

• Strong leadership, communication, and team management skills.
• Proven ability to collaborate cross-functionally with manufacturing, QA/QS, and other departments.
• Experience in manufacturing process management, quality assurance, or a related field is preferred.
• Bachelor’s degree in natural sciences or a related field is preferred.
• Project management or product ownership experience is a plus.
• Familiarity with Agile methodologies is advantageous.
• Experience with continuous improvement processes is highly valued.

Your Profile
On a personal level, you excel in coaching and guiding your team, providing clear direction, and communicating effectively. You can see the big picture of manufacturing operations while being detail oriented. You work independently while promoting collaboration with internal and external partners. Flexible and motivated, you thrive under pressure and can maintain an organized, results-oriented approach by aligning priorities. As a team player, you engage effectively with stakeholders at all levels.

Join an International and Agile Organization
At AGC Biologics, you will have the opportunity to work on diverse tasks and challenges, gaining experience across various departments. With a collaborative approach to planning projects and tasks, you will also have the opportunity to influence your day-to-day work. AGC offers an informal working environment where energy and enthusiasm are part of daily life. We respect each other's individual differences and have a flexible, team-oriented approach to meeting deadlines.

Contact and Application
For any questions, feel free to contact Martin Pierroff at [email protected].

Please note that only applications submitted via our career page will be considered. We will review applications as they arrive.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Location: Copenhagen Site