Senior Scientist, Quality Systems

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.

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 functional and have exposure to all –levels internal clients? Our Quality Systems team is looking for a new colleague. If you like continuous development and growth AGC Biologics is the place to be.

Do you have a compliance systems background and want to be responsible for the maintenance of the quality systems, Quality Risk Management oversight, and data trending of QMS processes?

Do you enjoy collaborating with internal and global partners, preparing, and providing guidance on execution of the processes referenced? Additionally, do you have experience as project lead of optimizing of quality systems and quality processes? This may be just the role for you!

Our Quality Systems team is looking for a diligent and customer-oriented Senior Scientist to join our team in Copenhagen.

About Quality Systems
Quality Systems 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 Quality Systems team is responsible for maintenance and development of our quality systems for etc. Quality Management Review, Deviation, CAPA, Change Management, Complaints, Training Management, and Document Control. We also have oversight of the Supplier Qualification program, internal and external audits, and regulatory inspections.

The team works closely together 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 keep an open communication with focus on a high level of professionalism. We are open-minded and committed to providing high-quality service to our colleagues in the rest of AGC Biologics and – and to our customers.

The role:
As a Quality Systems Senior Scientist, you will be responsible for the maintenance of the quality systems, performing Quality Risk Management oversight, supporting and handling complaints and recall and other relevant QMS processes.

The role collaborates actively, with internal customers from all GMP areas across the site and with our Global sites and our corporate quality organization.

Education/Training:

• Master’s degree in Natural Science, PhD, or equivalent.
• A minimum of 5 plus years’ experience required.
• Strong regulatory experience is required.
• Strong familiarity with regulatory requirements from FDA, DMA, EMA, and/or other regulatory agencies.

​Soft skills and competencies:

• Experience with Quality Risk Management, complaint and recall handling, and other QMS processes.
• Strong skills in writing procedures and SOPs.
• Strong written and verbal communication skills.
• Strong decision making and ‘can do’ attitude.
• Strong working knowledge of the principles and guidelines for GMP.
• Ability to actively develop and maintain strong professional relationships, building trust and respect across the organization
• Ability to lead through influence, effectively build alignment, and collaborate with multiple stakeholders.
• Ability to facilitate organizational change related to quality systems across multiple functions.
• Lean experiences is preferable.

AGC has international customers, and our company language is English. It is therefore required that communication in both written and spoken English is fluent.

We will process the candidates as they arrive. Therefore, please submit your application and CV as soon as possible. When the right candidates are found, the ad will close. We are therefore looking forward to receiving your application today!

For further information regarding the position, please contact Hanh Tuyet Dinh, Quality Systems Manager [email protected]

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.
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