Manager, 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 our new Supplier Quality Manager?
Do you enjoy working cross functional and have exposure to all –levels internal clients? Our Quality Systems team are looking for a Supplier Quality Manager.

About the Role
As Manager part of the Supplier Quality Management team (SQM), you’ll be responsible for managing a small team and executing the company’s supplier quality program and supporting a site manufacturing clinical and commercial drug substances. You’ll perform supplier evaluations, lead supplier audits, and support the site as a subject matter expert during audits and inspections. This role requires attention to detail, organization, and comfort interacting cross-functionally with internal and external partners.

About the Quality Systems department
(SQM) is part of the Quality Systems department and 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 within quality assurance, and you will report to Senior Director for quality system and be part of the leadership team in Quality Systems department.

We are actively involved in the constant development and improvement of the quality system and our facility in Søborg and have a close collaboration with our global AGC sites.

The team works closely together with the Quality Operations team, 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. 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, as well.

Responsibilities

• People manager for QS Supplier Qualification team
• Execute the ACG Biologics Approved Supplier Program for the site.
• Help develop the annual audit schedule.
• Schedule and perform audits with suppliers (including contract laboratories).
• Manage timely performance and closure of outsourced audits (i.e. audits conducted via consultants and other internal qualified resources).
• Manage supplier CAPA follow-up (as part of management of the audit response).
• Facilitating initial and lifecycle supplier qualification assessments.
• Manage the site’s Approved Supplier List.
• Act as supplier point-of-contact for quality-related topics.
• Optimize the Supplier Quality program through management of or participation in continuous improvement projects.
• Part of Global supplier communities
• Support customer audits and regulatory inspections as a Subject Matter Expert for Supplier Quality.

Candidate Profile

• Master’s degree or PhD in pharmacy, biochemistry, or related life sciences field.
• Minimum 2 years prior working experience in a Biotech/Pharmaceutical production environment, preferably with focus on supplier quality.
• People management experience
• Strong knowledge of GMP guidelines, as well as international regulations, pertaining to the production of biopharmaceutical products (including, but not limited to 21 CFR Parts 11, 210, 211, 600, and 610; EU GMP Parts I, II, and III, and relevant ICH guidelines).
• Proven technical writing skills.
• Proven ability to perform supplier audits.
• Skill in verbal communications. Ability to respond to complex inquiries from customers, co-workers, and supervisors regarding products and processes.
• Strong knowledge of Quality Assurance concepts related to supplier management activities.
• Skilled in time and priority management. Must be able to work under general direction to complete work tasks.
• Demonstrated ability to work collaboratively to accomplish deadlines and objectives.

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