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 global projects to improve QC labs competency and efficiency (organization, operational excellence, harmonization of LIMS, support New Product Introduction for QC activities)
Develop, implement and drive a comprehensive Quality Control oversight strategy and roadmap aligned with Corporate Quality and manufacturing sites Quality objectives to leverage compliance and efficiency for QC labs, global standardization / integration of analytical business processes and information, data integrity, global equipment standards and applications
Drive Aenova’s manufacturing sites QC topics and maintain global strategy and initiatives to ensure consistent and harmonized Quality Control standards across all laboratories (15 Quality Control Units)
Define QC performance & QC compliance related objectives and KPIs for manufacturing QC labs in agreement with Corporate Quality
Define, drive and ensure deployment of the future Aenova LIMS project across the different QC labs (Responsible for planning, budget and resource planning)
Provide input to the site’s Quality Control heads to ensure optimization of Quality Control capital investment plans (transparency of scheduled equipment recapitalization, new technology introduction, new IT applications & technologies needed).
Support the sites QC teams during Health Authority inspections, customer inquiries, visits, and audits providing technical expertise as needed
Oversee the execution of excellence projects for improving cost of good quality
Your profile
Minimum 15 years professional experience in the Quality Control Unit of a pharmaceutical, biotech or medical device company, in a senior role (e.g. Department Head)
Advanced Degree (e.g. PhD) in Pharmacy, Chemistry, Biology or related science
Proven track records in Operational Excellence / Lean 6 sigma certification, ideally Black Belt
Deep knowledge of the applicable regulations for drugs, related industry GxP standards and processes
Flexibility and agility in problem solving, providing direction to meet business objectives, capable to negotiate
Strong team player with clear communication skills, able to work in a matrix organization
Experience in collaborating across boundaries, cross cultural experience
Outstanding language skills in English, both in writing and verbally, any other language (German, Italian) 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