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.

Are you experienced in GMP training? Our QMS & Training team in Quality Systems department is looking for a new colleague.
Join the team to play a central role in enhancing our training standards to improve quality across the company. AGC Biologics is rapidly growing and is the place to be if you like development and growth in a collaborative and engaging atmosphere.

About QMS & Training team
QMS & Training team is part of the Quality Systems department and is an important part of the Quality organization.

You will be joining a team of highly qualified colleagues, all with several years of experience within quality assurance and GMP training.

The team is responsible for maintenance and development of our Quality Management Systems e.g.: Deviation, CAPA, Change Control, Complaints, Training, and Document Control.

The team works closely together 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 current GMP.

We keep open communication with a 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.

What will you do?
As our new colleague, you will collaborate with partners and drive improvement projects optimizing our GMP Training standards and systems such as our Training Management System, Trainer program, and “TWI based” Work Instructions program. You will continuously develop new training standards, courses, and programs to support the business needs and goals.

To excel in this role, the following qualifications and skills are essential:

• An academic degree and substantial training experience, preferably in GMP-regulated environments.
• Proven experience in planning and successfully executing projects.
• Confidence as a trainer with strong facilitation abilities.
• Familiarity with eLearning development, particularly in Articulate Rise and - Storyline.
• A team-oriented and service-minded approach.
• Effective verbal and written communication skills in English, with Danish proficiency as a bonus.
• Knowledge of Training within Industries (TWI) and LEAN are advantageous.

As a Person
You will be successful in this role if you are passionate about GMP Training. You should be able to build trustful relations with our partners and drive changes via your interpersonal skills. You are good at communicating and delivering your work in a timely manner and of a high quality. We have an informal atmosphere in the team where humor plays a big role.

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