Principal Scientist, Quality Management Systems & Training

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.

Do you enjoy working cross-functionally and engaging with clients at all levels? Do you have a compliance systems background and want to be responsible for maintaining quality systems? And are you looking for continuous development and growth? This position could be a great match for you!

Our Quality Systems (QS) team is looking for a diligent and customer-oriented Principal Scientist to join QS in Copenhagen. Read more below and apply today!

The QS Department:
QS is an important part of the Quality organization. You will be joining a diverse team of highly qualified colleagues, all with several years of experience in quality assurance. The QS team is responsible for maintaining and developing our quality systems, including Quality Management Review, Deviation, CAPA, Change Management, Complaints, Training Management, and Document Control. We also oversee the Supplier Qualification program, internal and external audits, and regulatory inspections.

The team works closely with the Quality Operations team and routinely collaborates with partners across all functional areas at the site and globally to ensure all quality-related activities are carried out effectively, efficiently, and in compliance with cGMP. We maintain open communication with a focus on professionalism and are committed to providing high-quality service to our colleagues and customers.

Role & Responsibilities:

As a QS Principal Scientist, you will be responsible for maintaining the quality systems, including:

• Lead site or global strategy projects for the Quality Systems Department.
• Develop cross-organizational and department-specific training programs.
• Evaluate and implement new technologies and methods for training.
• Conduct training in specific areas.
• Optimize main QMS processes.
• Manage Quality Risk.
• Participate in customer audits and authority inspections from EMA, US FDA, and other international authorities.
• Serve as a Subject Matter Expert on key SOPs and update Quality System processes related to your area of responsibility.
• Engage in global networking across the AGC Global Network.

Your Profile:

The ideal candidate holds a Master’s degree or PhD in pharmacy, biochemistry, or a related life sciences field. You would ideally have a minimum of 5+ years of experience and a strong regulatory experience. Further, a thorough familiarity with regulatory requirements from FDA, DMA, EMA, and/or other regulatory agencies is an advantage.

In addition, we are looking for a colleague with several of the following competencies and characteristics:

• Experience with GMP compliance, QMS processes and training.
• Strong written and verbal communication skills.
• Ability to develop and maintain strong professional relationships, building trust and respect across the organization.
• Proven ability to lead through influence, effectively build alignment, and collaborate with multiple stakeholders.
• Lean experience is preferable.
• Ability to facilitate organizational change related to quality systems across multiple functions.

Your Application:

Apply with your CV today! If we see a match, you’ll have a call with one of our recruiters to share more about what you can bring to the team. Are both sides still positive? Then we proceed to the assessment stage to assess key skills required for the job. We will be conducting interviews on an ongoing basis and will close the position once the successful candidate has been found.

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.