Head of Quality & Compliance, FvP/RP (m/w/d)

CordenPharma is one of the leading Contract Development and Manufacturing Organizations (CDMO) and develops and produces active pharmaceutical ingredients, medicines and associated packaging services on behalf of its customers as a “full-service” service provider. The group employs around 3,000 people.

Our network in Europe and the USA offers flexible and specialized solutions across five technology platforms: peptides, lipids & carbohydrates, injectables, highly potent active ingredients & oncology and small molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the benefit of patients.

CordenPharma International (CPI) acts as the management company of the CordenPharma Group. In addition to the Executive Leadership Team, CPI has central functions such as Sales & Marketing, Legal, HR and Corporate Development, which work for the CordenPharma Group across locations and at an international level.

We are looking for one as soon as possible

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 and influence a strong quality and compliance mindset for the entire site
• Use clear decision making, 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 healthy assertiveness, an independent and systematic way of working with a high level of initiative and responsibility
• Strong communication skills
• Working languages are German and English