Denmark Job Openings
AGC Biologics
Manager, Quality Systems
Copenhagen
FULL TIME
September 9, 2024
- 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.
- Master’s degree or Ph D 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.
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 (p DNA), messenger RNA (m RNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with c GMP-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
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