(Senior) Supplier Quality Specialist

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

Benefits offered by this job

International working environment

Professional development opportunities

Job summary

AGC Biologics in Søborg is seeking a Supplier Quality Management Specialist to strengthen the supplier quality function within a complex pharmaceutical environment. You will manage supplier qualification processes, audits, and quality agreements while acting as a subject matter expert during client audits and inspections.

The role requires a detail-oriented and pragmatic approach, with strong collaboration across internal teams and external partners.

Qualifications

• Minimum 2 years working experience in biotech/pharmaceutical environment focusing on supplier quality.
• Master's degree in a related life science field and strong GMP knowledge.
• Experience or training as a lead auditor is advantageous but not required; training can be part of development.

Responsibilities

• Participate in supplier qualification, assessments and ongoing performance evaluations to ensure supplier quality.
• Support planning, preparation and execution of supplier audits; potential lead auditor role if trained.
• Prepare, review and maintain Supplier Quality Agreements with internal and external partners.
• Support client audits and regulatory inspections as a subject matter expert on supplier quality.
• Collaborate with Material Science, Quality Control, Supply Chain Management and other functions; contribute to continuous improvement of supplier quality processes.

Skills

Supplier management

Audits

Quality agreements

Regulatory inspections

Technical writing

Verbal communications

Time management

Collaboration

Education

Master's degree in pharmacy/biochemistry/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

Your key responsibilities will include:

• 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, 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.
• Competi