Senior Supplier Quality Specialist

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 supplier quality management (SQM) audits and inspections Are you a trained Lead Auditor with great knowledge of GMP guidelines and experience from a pharmaceutical manufacturing environment We are looking for a Senior Supplier Quality Specialist to join our Supplier Quality Management team at AGC Biologics in Copenhagen Søborg! Read more below and apply today!

The Quality Systems (QS) Department & SQM Team:

The SQM Team is part of the broader QS Department and is an important part of big Quality organization. You will be joining a diverse team of highly qualified colleagues all with several years of experience within quality assurance and you will report to the Manager for the SQM Team.

We are actively involved in the constant development and improvement of the quality system for our facility in Søborg and we have a close collaboration with our global AGC Biologics sites. The team works closely together with the Quality Operations team and Supply Chain Management and routinely collaborates with partners across all functional areas at the site 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. And we are committed to providing high-quality service to our colleagues in the rest of AGC Biologics to our customers and to our suppliers as well.

The Specialist Role & Responsibilities:

Our QS Department supports our site in manufacturing clinical and commercial drug substances. You will be part of the SQM Team responsible forsupplier qualifications assessments and evaluations supplier auditsSupplier Quality Agreements and supporting the site as a subject matter expert during audits and we are looking for a new colleague who has experience with all aspects of Supplier Management and is a trained Lead Auditor. In this role you will also collaborate with the global SQM Community to drive the continuous improvement of our Supplier Management processes. The role requires comfort interacting cross-functionally with internal and external partners - and an attention to detail is an advantage.

Your Profile:

The key requirements of this role include that you hold a relevant Masters degree e.g. in pharmacy biochemistry or related life sciences field and have experience as a Lead Auditor e.g.: ISO 9001 GMP. The ideal candidate brings this solid foundation in combination with a minimum of 5 years of experience in a Biotech/Pharmaceutical production environment with a focus on supplier quality.

Further we would really like to hear from you if you recognize yourself amongst more of the following skills and characteristics:

• Strong knowledge of GMP guidelines as well as international regulations pertaining to the production of biopharmaceutical products (including but not limited to 21 CFR Partsand 610; EU GMP Parts I II and III and relevant ICH guidelines).
• Ability to be pragmatic and still ensure compliance.
• Proven technical writing skills.
• Skills in verbal communications. Ability to respond to complex inquiries from customers co-workers and suppliers.
• Skilled in time and priority management.
• Demonstrated ability to work collaboratively to accomplish deadlines and objectives.

Your Application & The Recruitment Process:

Are you interested We are looking forward to hearing from you! Submit your motivated CV no later than the 18th of February 2026. We will be reviewing CVs and calling relevant candidates on an ongoing basis. The Manager Lise Mosegaard expects to conduct interviews during February and March on an ongoing basis and until the right candidate is found. We aim at a start date of 1st of May 2026 or as soon as possible hereafter. If you recognize yourself across the majority of the experience but not all we still encourage you to apply.

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 2500 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.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.