Senior QC Project Coordinator, Quality Control

QC Project Coordinator – Drive Innovation in Biopharmaceutical Quality Control

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 an experienced professional with a passion for coordinating analytical activities and leading projects in a dynamic, international environment? Do you thrive in cross-functional roles that bridge technical expertise, project management, and regulatory compliance? If so, we invite you to explore this exciting opportunity to join our Quality Control (QC) team as a QC Project Coordinator.

As a QC Project Coordinator, you will play a pivotal role in ensuring the seamless execution of QC activities that support clinical and commercial manufacturing. Acting as the key link between QC teams, external customers, and internal stakeholders, you will drive progress, ensure compliance, and deliver results that meet the highest standards of quality and efficiency.

This is more than a coordination role—it's an opportunity to lead, strategize, and contribute to the success of cutting-edge biopharmaceutical projects. You will represent QC in customer and core project teams, lead cross-functional analytical teams, and provide strategic input to optimize processes and ensure regulatory compliance.

At AGC Biologics, we are committed to innovation, collaboration, and excellence in biopharmaceutical manufacturing. As part of our QC Chemistry Department, you will work alongside talented professionals in a fast-paced, supportive environment that values your expertise and contributions. You will have the opportunity to:

• Lead impactful projects that shape the future of biopharmaceutical production.
• Collaborate globally with internal teams, customers, and external partners.
• Grow professionally through exposure to diverse challenges and opportunities for process improvement.

Key responsibilities include:

• Project Leadership: Represent QC in customer and core project teams, acting as the single point of contact for QC-related matters. Lead cross-functional QC analytical project teams to drive progress and meet milestones.
• Analytical Coordination: Oversee method validations, transfers, and batch release schedules. Collaborate with QC subject matter experts to ensure timely execution.
• Documentation and Compliance: Write, review, and approve GMP documentation, including CAPAs, deviations, CoAs, and change control cases.
• Strategic Input: Advise management on QC-related matters, contribute to process optimization, and establish/update specifications for Drug Substance and Drug Product.
• Regulatory Support: Participate in regulatory inspections (e.g., DMA, FDA) and customer audits.
• Relationship Building: Foster strong communication and collaboration across departments, with customers, and external partners.

We are seeking an experienced candidate who brings a blend of technical expertise, project management skills, and a proactive mindset. The ideal candidate will have:

• Educational Background: MSc in Chemistry, Biochemistry, or a related field with 2–6 years of relevant experience; or PhD with 3 years of relevant experience.
• Project Management Expertise: Proven ability to manage multiple projects, oversee milestones, and drive coordination across stakeholders.
• GMP Knowledge: Hands-on experience working in cGMP settings under EU and US regulatory guidelines.
• Communication Skills: Strong interpersonal skills to build relationships and effectively communicate with internal and external stakeholders.
• Language Proficiency: Fluency in English (written and spoken). Interest in learning Danish is an advantage.

A dynamic and collaborative work environment that values innovation and teamwork.

Opportunities to lead impactful projects and contribute to the success of global biopharmaceutical manufacturing.

Professional growth through exposure to diverse challenges and opportunities for process improvement.

Competitive compensation and benefits package.

If you are an experienced professional looking for a challenging and rewarding role in biopharmaceutical quality control, we encourage you to apply. Join us at AGC Biologics and be part of a team that is shaping the future of medicine.