Copenhagen, Denmark

Are you a Compliance Scientist looking for a new career opportunity? Do you enjoy working cross functional and have exposure to all –levels internal and external customers? Our Quality Systems team is growing and we are looking for a new colleague. If you like continuous development and growth AGC Biologics is the place to be.

Do you have a compliance systems background and want to be responsible for the maintenance of the quality systems and processes for Quality agreements for customers and suppliers? Do you enjoy collaborating with internal and global partners, to prepare and provide guidance on execution of the processes referenced ? This may be just the role for you!

Our Quality Systems team is expanding and we are looking for a diligent and customer-oriented Compliance Scientist to join our team in Copenhagen.

About Quality Systems
Quality Systems 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.

The Quality Systems team is responsible for maintenance and development of our quality systems for etc. deviation, CAPA, change management, complaints, training management, and document control. We also have oversight of the supplier qualification program, internal and external audits, regulatory inspections, and customer quality agreements.

We are also actively involved in the constant development and improvement of the quality system and our facility in Søborg.

The team works closely together with the Quality Operations team, and routinely collaborates with partners across all functional areas at the site and globally, 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.

The role:
The Compliance Scientist plays a critical role in the maintenance of the quality systems and processes. The role collaborates actively, with internal customers from all GMP areas across the site, External customer, and suppliers to update or establish quality agreements. You will take up the process lead role for the Quality agreement.

Principal responsibilities:

• Update or create new Quality agreements for external customer and Suppliers.
• Collaborate with internal and external stakeholders to implement and optimize the current process for Quality agreements.
• Educate internal stakeholders on the process.

Education/Training:

• Bachelor degree in Chemistry, Biochemistry, Pharmacy, or similar
• Preferably 3+ years’ experience working in a cGMP environment.

Soft skills and competencies:

• Strong written and verbal communication skills.
• Actively develops and maintains strong professional relationships building trust and respect across the organization
• Lead through influence, effectively build alignment and collaborate with multiple stakeholders
• Experience with Quality agreement work are preferable.

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.