Senior Manager, QA Facility & Equipment

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 looking to accelerate your career as a people manager within Quality Assurance (QA) Are you driven by the purpose of the biopharmaceutical industry and eager to make a difference for patients worldwide through your impact on the QA agenda Due to moves internally supporting the growth and development of our people leaders this rare job opportunity of a Senior QA Manager is now open! Read more below and apply today!

Note: This role is required to be onsite in our facility in Søborg and cannot be remote. Thus we only consider applications from candidates who are eligible to work in Denmark and available to come onsite to Søborg - both for the interviews and for the daily work as a Senior Manager in QA.

QA Facility & Equipment:

You will be joining the QA Department consisting of over 80 colleagues with primary responsibilities in Manufacturing Raw Materials Quality Control and Facilities and Equipment. The QA Facilities & Equipment team is comprised of highly qualified scientists with diverse professional backgrounds and several years of experience in the field of QA. The main objective of the team is to ensure that our production facilities and laboratories comply with current GMP standards including EU GMP 21 CFR and ICH guidelines at all times. The team is mainly responsible for the review and approval of quality documentation including equipment qualifications IQ OQ PQ environmental monitoring cleaning validation deviation handling and approval of CAPA and change requests.

You Will Get A Pivotal Role In QA:

Overall we are looking for a Senior QA Manager who thrives and excels when no day looks the same and the dynamics and pace of our environment kicks in. It is an advantage if you can navigate ambiguity and balance the demands of high quality and tight deadlines for yourself and for your team. You will be translating strategy into operating plans and drive productivity. And you will be providing input into process and policy improvement and administering budgets timelines and performance requirements.

You will be the primary responsible for ensuring quality oversight by coordinating with other departments to ensure that all activities related to facilities and equipment are in compliance with relevant regulations. A continuous success-criteria in this role is building cross-functional collaboration and considering the various perspectives of other stakeholders across the business e.g. our colleagues in Engineering or IT. Your tasks include:

• Proactively addressing GMP compliance and partnering with other departments/groups to problem solve and address complex compliance issues.
• Representing QA in cross-functional project teams for more complex projects related to facilities and equipment.
• Communicating complex ideas anticipating potential objections and guiding others often at senior levels to adopt a different point of view.
• Assimilating feedback from other teams to achieve successful work processes within function/group.

Solid QA Experience:

You will become a part of a highly skilled Quality department with colleagues of various educational backgrounds in natural sciences and across all types of degrees including PhD. It is therefore a significant advantage if you hold a Masters degree from a relevant field of studies in natural science chemical engineering or similar.

As a Senior Manager in QA we expect you to have 8 years of relevant industry experience and proven experience in an FDA-regulated environment with a strong understanding of GMP (Good Manufacturing Practices) ICH guidelines and regulatory order to succeed in this role you must have experience with audits and inspections since you will be leading teams supporting regulatory inspection readiness. Further this role requires in-depth knowledge of facilities and equipment qualification software validation and maintenance in a GMP environment. If you have experience implementing quality systems and driving continuous improvement initiatives it is an advantage but not a requirement.

Proven Leadership Skills:

In combination with your educational background and quality experience we are looking for a leader who brings proven managerial experience preferably a minimum of 4-5 years. As a people manager your tasks include:

• Ensuring the clarity of responsibilities and priorities as well as performance level of direct reports and their professional development through your coaching as part of leadership style.
• Creating high level of team spirit and engagement promoting and living the core values.
• Managing cross-functional teams and communicate effectively with stakeholders at all levels including technicians scientists managers directors and VPs. You will be leading across the organization to ensure effective performance throughout the value chain.

The Recruitment Process & Your Application:

Are you interested We are looking forward to hearing from you! Submit your motivated CV no later than the 5th of February 2026. We will be reviewing CVs and calling relevant candidates on an ongoing basis. The QA Director Lotte Nymann Göransson expects to conduct the first round of interviews no later than week 7 and the second rounds in the beginning of week 9. We are aiming at a start date of 1st of April 2026 or as soon as possible hereafter. If you dont hold the preferred educational background but recognize yourself across the majority of the QA experience and people management skills we do 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.