Derks Vacature Kwaliteit

QA Manager

  • Fulltime
  • Vast
  • Groningen

Derks & Derks

Broad quality position within an ambitious and international biopharmaceutical company

Offer
  • broad quality role within a driven and ambitious organisation
  • diverse team with different nationalities in an international industry
  • responsibility for the further development and design of the quality policy
  • open and enthusiastic culture with plenty of personal development opportunities
Position

As Quality Assurance Manager you are responsible for the overall quality policy, quality procedures, quality system and the overall safety policy. You ensure adherence to internal quality procedures, and that these internal quality procedures are compliant to the applicable current national and international regulations and guidelines (EMA, FDA, ICH). Also, you support and advice Project Managers regarding quality issues within projects where applicable. Furthermore, you will manage the internal and supplier audit program and manage regulatory inspections and customer quality audits. As a QA Manager you will be the point of contact and source of information for all matters concerning quality. You will provide advice and assistance to the different departments, projects, and the management team in quality and regulatory matters. You will be working in close collaboration with the QA Officer, Manager Operations and Quality Control and department Quality Coordinators.

In this position of QA Manager, you are also responsible for the overall safety, health, and environment policies. You will be the lead in developing and monitoring the policies on safety, health, and environment. You create more awareness and ensure that the policy really becomes part of the company culture. Also, you are responsible for the risk assessment and evaluation (RI&E), the implementation and regular evaluation of the measures. Furthermore, you challenge, support and advice the organisation regarding safety issues and risk assessments where applicable. As a QA Manager you will report to the Chief Executive Officer (CEO) and will have one direct report (QA Officer, 0.6 fte).

Profile
  • completed MSc or PhD degree in Analytical (Bio)Chemistry, biotechnology, (Bio)Pharmaceutical Sciences or a related discipline
  • at least 5 years of experience within Quality Assurance in a pharmaceutical or biotechnology company
  • broad knowledge of quality systems, audits, and inspections in the pharmaceutical industry
  • knowledge of regulatory landscape related to drug development and IP/licensing
  • communicative, analytical, pragmatic and a drive to get things done
  • strong client focus and consistently improving performance
Organization

Our client is a biopharmaceutical company located in the city of Groningen. They are specialized in the development of complex injectable drug delivery products with improved therapeutic efficacy and fewer side effects. They are known as a customer focused center of excellence with an unsurpassed drive to provide solutions for growing international pharmaceutical companies. Their international multi-disciplinary team of around forty experts is specialized in the development of microparticle-, gel- and implant-based injectable sustained release formulations for the treatment of a variety of chronic diseases. They have an extensive track record in pharmaceutical development and offer cGMP manufacturing of clinical supplies through a network of qualified CMO’s. This young and ambitious team of co-workers offers a responsible and challenging position in a modern and well-equipped laboratory. The organisation is committed to offer the best possible environment for their employees, where people are challenged and supporter to further develop themselves.

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WS/22-125-DD, to Tim van Loon: info@derksenderks.nl.

For further information you can call, text or WhatsApp with Tim van Loon on number +31 (0)6 20 79 77 21

An individual assessment is part of the selection procedure.

Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

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