Quality Assurance Manager (m/f/d)

Site Qualification

Our client is a worldwide leading operating biopharmaceutical enterprise whose German subsidiary is based in Munich. He is one of the most important research-based biopharmaceutical companies in the world and his global-leading approach to address unmet medical needs for patients with life-threating diseases is revolutionary.

 

Our client has a well-known history in scientific breakthroughs. He has recently developed innovative new therapeutics and advanced care of patients confronting life-threatening diseases in the therapeutic areas of HIV, Virology and Oncology - and yet more to come.

 

We are recruiting a.s.a.p. for a dedicated and experienced:

Quality Assurance Manager (m/f/d)

Site Qualification

  • Bereich:

    Medical

  • Berufssparte:

    Qualitätswesen/Qualitätsmanagement

  • Arbeitsregion:

    Greater Munich

  • Art der Anstellung:

    Permanent

  • Kennziffer:

    25371

  • Aktualisierung:

    23.07.2019

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Your responsibilities

  • Assist in the execution of quality agreements with German Apheresis and Treatment centers  and in the management of gATC qualification process that will use risk-based tools for qualification, training, monitoring and disqualification
  • Perform qualification audits, qualify and monitor compliance to qualification requirements as needed
  • Assist with resolution of gATC issues and discrepancies, and the investigations to resolve the issues and on the quality aspects of the implementation of an apheresis collection system in Germany
  • Assess and approve any changes to collection app, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained
  • Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
  • Collaborate with our Quality Team in the Netherlands on product supply and distribution inquiries in Germany
  • Perform other duties as assigned

Your qualifications

  • Bachelor’s degree in  biological sciences, nursing, medical technologist or related field
  • Relevant experience in and extensive knowledge of cGMP and quality assurance in conformance with Germany standards
  • Medical center or pharmaceutical auditing experience and experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers preferred
  • Relevant experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, preferred; OR pharmaceutical, vaccines or biologics quality systems’ roles
  • Experience managing external suppliers, blood banks, and plasma centers
  • Previous experience presenting and responding to regulatory agency or certification audits, preferred and experience with managing supply and quality contracts with hospitals
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Relevant experience working in multicultural and cross functional teams
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
  • Ability to travel up to 20%
  • Proficiency in German (native) and English
  • Proficient in MS Word, Excel, and Power Point

Ihr Ansprechpartner

Osmarina Pereira
Senior Personalberaterin

Anschrift

Optares Medical GmbH & Co. KG
Osmarina Pereira
Heiligengeist Höfe 8
26121 Oldenburg