Head of Quality Biopharma Germany (m/w/d)

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Ansprechpartner
Nadja Küppers
+49 (0)89 7263 210 – 09
kueppers@ageneo.de
Branche
Pharmazeutische Industrie
Berufsfeld
QM
Region
Germany

DAS UNTERNEHMEN

Our client, one of the leading, most well-known, international working (bio)pharmaceutical companies is looking for a "Head of Quality Biopharma" (f/m/d). In this interesting role you would take on the managerial leadership of a Quality Biopharma team of over 700+ employees with the objective to continuously improve  the existing cGMP quality management system according to internal as well as external regulations.

IHRE AUFGABEN

  • Taking on the managerial leadership of Quality Biopharma  with the objective to continuously improve the existing cGMP quality management system according to internal as well as external regulations in order to safeguard the License to Operate for world-wide supply of clinical as well commercial products.
  • Responsibility for the end-to end Quality oversight of the process and product lifecycle activities at the site, which includes the quality control of intermediate, DS, DP, FINP, Combination Products & Devices according to established internal and external standards
  • Setting high standards of performance and ensure compliance across the various functions – including ensuring team compliance with EHS, CGMP, SOPS and other documentations
  • Taking into account site-specific requirements and compliance with global standards and regulations, being accountable for an efficient quality management system and ensure market supply and compliance status/inspection readiness of Biopharma in Germany
  • Responsibility for leading and overseeing the quality operations with direct and indirect reports of about 700+ employees
  • Reporting to the Global Head Biopharma Quality, being a member of the Global Quality Biopharma Leadership Team and as such, you playing an instrumental role for driving the Quality development roadmap 
  • ensuring an environment of consistent quality and compliance in all activities across the site and that, the site is global health authority inspection-ready at all times

IHR PROFIL

  • University degree in Biopharmaceuticals or Pharmaceutics with long-term professional experience in an international context in the biotech industry compared with extensive knowledge in Quality Assurance and Quality Control. Preferably, in addition experience in manufacturing of Biopharmaceutical Products and drug analysis
  • Versatile senior quality professional and leadership candidate who can manage the aspects of multi-product facilities, establishing Q oversight from cell line development through final filled product, interaction with CMO, CRO, CLO at various stages of the product lifecycle
    In depth, technical Skills in (Aseptic) Pharma-Manufacturing combined with a proven track record in at least one of the following fields: Drug Substance, Drug Product, Devices etc.
  • Successfully led large-scale business planning processes which included the development and implementation of such plans, goals and metrics
  • Courage to lead an agile organization of +700 FTE and willing to take on the responsibility for informed-risk taking
  • Eagerness to shape and develop/grow oneself and the organization at the same time
  • Change agent: expertise in organizational change management to develop the existing culture and behavior to make it sustainable
  • Comprehensive strategic thinking skills and ability to translate strategies into tangible actions
  • Fluent in English and willingness to learn German – clear and concessive communicator, willing to take a stand and intelligent, informed risks

BENEFITS

  • Leading a huge team in the field of quality with high impact and exposed function 
  • One of the most well-known international working biopharmaceutical companies
  • Excellent opportunities for further development
  • Excellent team environment
  • Opportunity for change management
  • Competitive benefits and excellent corporate culture