Analytik NEWS
Online Laboratory Magazine
05/02/2024

Vice President Operational Quality Germany (m/f/d)

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Your Profile:

  • Minimum 15 years of professional experience in the Quality Unit of a pharmaceutical, biotech or medical device company, in a senior manager role (e.g. Department Head)
  • Advanced Degree (e.g. PhD) in Pharmacy, Chemistry, Biology or related science
  • Demonstrated knowledge and experienced in execution of Quality Operations
  • Deep knowledge of the applicable regulations for drugs
  • Flexibility and agility in problem solving, providing direction to meet business objectives, capable to negotiate
  • Strong team player with clear communication and excellent leadership skills, able to work in a matrix organization
  • Outstanding language skills in English and German, both in writing and verbally, any other language is a plus

Your Tasks:

  • Lead and manage a team of 8 Quality Units responsible for manufacturing sites in the region of Germany
  • Develop and implement a comprehensive Quality oversight strategy and roadmap (Annual Quality Plan) aligned with business and site operations objectives as well as a holistic Quality Culture Concept enabling a constructive and sustainable "One Quality" mindset
  • Drive Aenova's manufacturing sites Quality topics and ensure that Corporate processes and systems are deployed at the manufacturing sites
  • Define Quality performance & quality compliance related goals, objectives and KPIs for Factories in agreement with Corporate Quality
  • Support designing and oversee fulfillment of CAPA plans from Health Authority inspections as well as Corporate and customer audits
  • Provide technical and regulatory guidance, perform coaching and personnel development as well as performance evaluations and talent management
  • Serve as escalation point for all critical and major Quality events (especially complaints, deviations, OOS) and as primary Corporate Quality point of contact for the Site Heads
  • Oversee the execution of excellence projects for improving cost of good Quality


» Job description


Employer:
Aenova Group
Location:
82319 Starnberg
Temporary:
No
Type:
Full-time