Due to expansion of our facility in Copenhagen and still increasing activities AGC Biologics are looking for a Sr. Manager in Quality, Facility and Equipment, with experience in international and national standards of equipment and facility validation/ qualification as required  in a GMP aseptic manufacturing  facility of biological API for phase I-III clinical trials and commercial manufacturing. AGC Biologics are growing and we are building a new mammalian production facility in CPH to be in use from Q3 2023. Beside the new building also activities of new equipment and facility rebuilds are expanding.

About the role and your profile:

As Sr. Manager in Quality, Facility and Equipment, Facility and Equipment (FE) you will have the daily management of an expanding team of highly qualified scientists and Subject Matter Experts.

You will be overall responsible for the quality oversight for our Equipment and Facility approved according to  European Directive 2001/83/EC, 2017/1572 as well as FDA 21 CFR 210 and 211, including aspects of ASTM2500. Your area of responsibility will include current manufacturing facility and our expansion project.

At AGC, we use on a risk based validation approach and it will be your department overall responsibility to keep our  policies updated with current regulatory expectations as well business expectations. This is done in close collaboration with our validation team that is the teams closest collaborators.

We are actively involved in the constant development within our field and the continuous improvement of our quality system. We ensure that Manufacturing, Engineering, and QC are in compliance with standards for cGMP production, i.e. EU GMP, 21 CFR and ICH guidelines, and you will be a important collaborator on defining world wide policies as well as ensuring quality oversight and compliance of procedures.

You will cover strategic and tactical leadership for the Quality Facility and Equipment team responsible for procedures and policies for equipment and facility validation/ qualification as well as procedures and policies for general compliance of Facilities and Equipment as Cleaning, Environmental Monitoring, Computerized Systems, FE Deviations and CAPA and FE Change management.

The team is additional an active contributor to Customer Audits and Regulatory Inspections.

Quality FE, consists of highly qualified scientists with various professional backgrounds and several years of experience within Quality Assurance and validation.

Your responsibilities as a Sr. Manager and functional lead:

  • Provide leadership and vision to drive a quality culture by developing a risk based quality strategy to ensure business goals.
  • Department management ensuring a staff training program and a talent management program for the team
  • Budget responsible for the department.
  • Overall responsible for ensuring Quality Oversight for our Facilities and Equipment
  • Participate in CAPEX meeting to timely plan execution of validation activities in collaboration with our Validation team.
  • Ensure effective and compliant validation processes and engage in cross-functional planning to leverage resources to improve speed of resolution
  • Partner with community peers at the operational sites to share and adopt best practices across the network to drive continuous improvement.
  • Align local procedures and policies with global policies. Partner with with global quality teams to set a “state of art” policy for facility and equipment
  • Routinely participate in internal and external audits and inspections.
  • Contribute to Annual Product Review  and BLA process for commercial projects

We are conducting interviews on an on-going basis, so please apply as soon as you can and we'll contact your if you're selected. 

For any enquires about the role and the team, please contact Lise Christensen, Senior Director QA, directly to +4522943058

 

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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.

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