Do you enjoy working cross functional and have exposure to all –levels internal clients? 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 Customer and suppliers? Do you enjoy collaborating with internal and global partners, to prepare and provide guidance on execution of the processes referenced and do you have experience as project lead of optimizing of quality systems and quality process? This may be just the role for you!

Our Quality Systems team is expanding, and we are looking for a diligent and customer-oriented Principal Scientist, Data manager 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. Quality management review, 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 Data Manager is a new role in my team and will plays a critical role in the maintenance of the quality systems and processes and you will take up the process lead role for Quality trending. The role collaborates actively, with internal customers from all GMP areas across the site and with our Global sites and our corporate quality organization.

Education/Training:

Master’s degree in Natural Science, PhD, or equivalent.
A minimum of 5 plus years’ experience required.
Strong regulatory experience is required.
Strong familiarity with regulatory requirements from FDA, DMA, EMA, and/or other regulatory agencies.

Soft skills and competencies:

Experience with Data management and trending
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

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

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.

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However, we have taken appropriate safeguards to require that your Personal Data will remain protected in accordance with this Policy. These include implementing an intra-group data transfer agreement based on the European Commission's Standard Contractual Clauses (the "Intra-Group Data Transfer Umbrella Agreement") for transfers of Personal Data between our group companies, which require all group companies to protect Personal Data they process from the EEA in accordance with the GDPR.

We have implemented similar appropriate safeguards with our third party service providers and partners and further details can be provided upon request.

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