Head of Quality

vor 1 Woche

Aesch, Schweiz unisite AG Vollzeit

DSM Pentapharm, part of the nutrition cluster of the DSM group, is a Swiss SME with a long-standing tradition as an innovative and reliable supplier of active ingredients for the personal care, pharmaceutical and haemostasis diagnostics industries.

Position

Pentapharm covers the three business areas of Pharma, Diagnostics and Cosmetics. The Head of the Quality & Regulatory Department is a member of the Pentapharm Executive Board reporting directly to the CEO. This position represents Pentapharm internally and externally in all aspects of Quality Assurance, Quality Control and Regulatory Affairs. Besides leading the Quality Department, he/she is interacting with all departments of Pentapharm and setting the internal quality standards.

Aufgaben
- Leading the Quality & Regulatory Department
- Accountable for Pentapharm Pharmaceutical Quality System (ICH Q10) and for the execution of the Management Review as well as setting standards for continually improving the Pharmaceutical Quality System
- Ensuring compliance with all applicable regulations
- Strong focus on cross functional collaboration
- Acting as FvP (Fachtechnisch verantwortliche Person) according to Swissmedic regulations and supporting as PRRC (Responsible for Regulatory Compliance) according to EU IVDR 2017/746 regulation
- Coaching, developing, and fostering a team of approximately 25 employees
- Ensuring SHE requirements among the department are being met and followed
- Allocating departmental resources in the most efficient way and maintaining the quality budget
- Being a member of Pentapharm management team

Qualifikation
- University degree preferably in pharmaceutical or natural sciences
- About seven years of experience in the pharmaceutical industry, preferably in the area of quality
- Extensive knowledge of the applicable regulations (GMP EudraLex Vol.4 Part II), ISO 9001:2015, ISO 22716, ISO 13485:2015 and IVDR regulation (EU 2017/746)
- Proven experience in team leadership and coaching as well as promoting a culture of communication & collaboration
- Ability to work independently and solution-oriented
- Strategic and conceptual mindset paired with strong decision-making skills and sense of urgency
- Excellent communication skills, open minded and attentive
- High degree of creative drive, willing to break grounds and implement new things
- Fluent in German and English

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