Head of Quality & Compliance, FvP/RP (m/w/d)
CordenPharma ist ein führender Anbieter für die Entwicklung und Herstellung von pharmazeutischen Wirkstoffen (APIs), Hilfsstoffen,Fertigarzneimitteln und Verpackungsaktivitäten mit mehr als 2.800 Mitarbeitenden weltweit. Mit unseren Dienstleistungen unterstützenwir Pharma- und Biotech-Unternehmen bei der Herstellung von Medikamenten mit dem vorrangigen Ziel, das Leben der Menschen zu verbessern.
Unser Netzwerk in Europa und den USA bietet flexible und spezialisierte Lösungen auf sechs Technologieplattformen: Peptides, Oligonucleotides, Lipids & Carbohydrates,Injectable, Highly Potent & Oncology; and Small Molecules. Wir sind bestrebt in all diesen Bereichen höchste Qualität zum Wohl der Patienten zu liefern.
Zum nächstmöglichen Zeitpunkt suchen wir am StandortEttingen eine/n
Ettingen, Basel-Land, Schweiz
- Ettingen
- 01.01.2025
- Vollzeit
- unbefristet
As a member of the site leadership team, the Head of Quality & Compliance and Swiss Responsible Person (FvP/PR) is responsible for the entire Site Quality Management and Compliance as well as the management and leadership of the Quality team of around 20 people. The position functionally reports to the global Chief Quality & Compliance Officer based in Basel.
- Ensure the site delivers and practices the highest standards for products produced in compliance with GMP and Corden Pharma Corporate standards
- Lead customer negotiations on all quality and compliance matters to be a trusted partner
- As a member of the site leadership team, define andinfluence a strong quality and compliance mindset for the entire site
- Useclear decisionmaking, collaboration and effective execution to fulfil the local site quality strategy and collaborate with other Corden Pharma global sites
- Engage and motivate the site quality unit to continually improve capabilities in learning, customer service, innovation, analytics and lean quality management
- Be the site contact for Health Authorities meeting FvP / RP registration requirement
- PhD or Masters in pharmacy/chemistry
- Minimum of 10 years of experience in the pharmaceutical/CDMO industry at EU / FDA regulated production sites within the area of quality with proven knowledge of GMP and compliance requirements
- Agile and goal-oriented leader with an entrepreneurial mindset and several years of team leadership experience
- Extensive knowledge of quality systems, laboratory processes and equipment, computer system validation, quality assurance, quality control, data integrity concepts
- High level of social competence and a healthyassertiveness, an independent and systematic way of working with a high level of initiative and responsibility
- Strong communication skills
- Working languages are German and English
Lieu de travail
Brühlstrasse 50
4107 Ettingen
