Vice President Operational Quality Germany

vor 4 Monaten

Starnberg, Deutschland Aenova Holding Vollzeit

for the site Starnberg (Percha), Germany

Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Our site in Starnberg is the headquarters of the Aenova Group.
Your key responsibilities
- 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

**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 motivation

Are you looking for new challenges in a highly competitive environment? And you want to tackle them creatively and on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions rather than problems? What are you waiting for? We would be happy to explain our corporate benefits in a personal conversation

If you have any questions, I - Melanie Rümmele / Human Resources - will be happy to help you: +49 151 57915557

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