(Senior) Supplier Quality Specialist

AGC Biologics; København; On-site; DKK 700,000 - 900,000; Full time

Benefits offered by this job

International work environment

Competitive compensation & benefits

Pension and health insurance

Training and development opportunities

Copenhagen-area employee activities

Job summary

AGC Biologics is seeking a Supplier Quality Management Specialist to strengthen our SQM team at the Søborg site. You will handle supplier qualifications, assessments, audits and quality agreements, while supporting client audits and regulatory inspections.

The role requires collaboration across Quality Systems and other functions to ensure GMP-compliant supplier performance. You will join a small team with room to develop into a Senior Specialist level depending on experience, and you will

Qualifications

• Minimum 2 years prior working experience in a Biotech/Pharmaceutical environment, with a focus on supplier quality.
• Master’s degree in pharmacy, biochemistry, or related life sciences field.
• Strong knowledge of GMP guidelines and international regulations pertaining to biopharmaceutical production (21 CFR Parts 11, 210, 211, 600, 610; EU GMP Parts I–III; ICH guidelines).
• Experienced lead auditor is an advantage but not required.

Responsibilities

• Participate in supplier qualification, assessments and continuous performance evaluations to ensure quality requirements are met.
• Support planning, preparation and execution of supplier audits; lead auditor training/development can be part of your growth plan.
• Prepare, review, negotiate and maintain Supplier Quality Agreements with internal/external partners.
• Act as subject matter expert on supplier quality during client audits and regulatory inspections.
• Collaborate with Material Science, Quality Control, Supply Chain Management and other functions at the site and AGC’s global network.
• Contribute to development and improvement of supplier quality processes and the site’s quality management system.

Skills

Detail-oriented

Technical writing

Verbal communication

Time management

Collaboration

Education

Master’s degree in pharmacy, biochemistry, or life sciences

Job description

Our Quality Systems team is looking for a new colleague to strengthen our Supplier Quality Management team at AGC Biologics in Søborg.

Are you interested in supplier quality, GMP compliance and working with internal and external partners in a complex pharmaceutical environment? Do you enjoy working with quality processes, assessments and continuous improvement? Then you may be the colleague we are looking for.

About The Role

As a Supplier Quality Management Specialist, you will join a dedicated team currently consisting of a Scientist and a Senior Scientist. The team supports site manufacturing of clinical and commercial drug substances and is responsible for ensuring that our suppliers meet the required quality standards and regulatory expectations.

You will work with different aspects of Supplier Quality Management, including supplier qualifications, assessments and evaluations, supplier audits, and Supplier Quality Agreements. You will also support the site as a subject matter expert during client audits and regulatory inspections.

We are looking for someone who is interested in supplier management, willing to learn and motivated to contribute to a busy and complex environment. The role requires attention to detail, a pragmatic approach to quality and the ability to collaborate effectively with internal and external stakeholders.

Depending on your experience and qualifications, the position may be filled at Specialist or Senior Specialist level.

Your Responsibilities

• Supplier Management: Participate in and manage supplier qualification, assessments and ongoing performance evaluations to ensure suppliers meet AGC Biologics' quality requirements.
• Supplier Audits: Support the planning, preparation and execution of supplier audits. If you are already a trained or certified lead auditor, you may take a leading role in conducting audits. If not, auditor training and development can be part of your development plan.
• Quality Agreements: Prepare, review, negotiate and maintain Supplier Quality Agreements with internal and external partners.
• Audit and Inspection Support: Support the site as a subject matter expert on supplier quality matters during client audits and regulatory inspections.
• Cross-Functional Collaboration: Work closely with Material Science, Quality Control, Supply Chain Management and other functional areas at the site, as well as colleagues across AGC's global network.
• Continuous Improvement: Contribute to the development and improvement of supplier quality processes and the site's quality management system.

About The Quality Systems Department

Supplier Quality Management (SQM) is part of the Quality Systems department and plays an important role within the site's Quality organisation.

You will join a diverse team of highly qualified colleagues with extensive experience in Quality Assurance. The team works closely with Material Science, Quality Control and Supply Chain Management, as well as partners across all functional areas at the site.

We also collaborate with other AGC sites globally to ensure that quality-related activities are carried out effectively, efficiently and in compliance with cGMP requirements.

We value open communication, professionalism and a collaborative approach. Our goal is to provide high-quality support to colleagues across AGC Biologics, our customers and our suppliers.

You will report to the Manager of the Supplier Quality Management team.

What We Are Looking For

We are looking for a colleague who is detail-oriented, pragmatic and comfortable working with quality requirements in a regulated environment.

As a Person, You Have

• The 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.

You Also Have

• Minimum 2 years prior working experience in a Biotech/Pharmaceutical environment, with a focus on supplier quality.
• Master’s degree in pharmacy, biochemistry, or related life sciences field.
• 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).
• Experienced lead auditor (e.g.: ISO 9001, GMP) is an advantage but not a requirement.

If you do not have lead auditor training or certification, this can be part of your professional development.

What We Offer

At AGC Biologics, you will become part of an international organisation where quality, collaboration and continuous improvement are essential to what we do.

We Offer

• An international working environment with opportunities for professional development and collaboration across global sites.
• Competitive employment conditions, including salary, bonus schemes, pension and health insurance.
• Opportunities for training, development and cross-functional knowledge sharing.
• A strong focus on work-life balance, employee well-being and a supportive working environment.
• A variety of company and Employee Club activities in Copenhagen.
• A flexible and trust-based working culture with an open and collaborative approach.
• The opportunity to contribute to our purpose: Bringing Hope to Life.

Deadline: 29 November.

Applications are reviewed on an ongoing basis, and we reserve the right to close the vacancy before the application deadline if a suitable candidate is identified.

Please note that AGC Biologics does not offer relocation assistance. Applicants must already reside in Denmark or the Greater Malmö area in Sweden.

We look forward to receiving your application!

Who We Are

AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Denmark. From our Søborg site, we develop and manufacture life‑changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.