Head Quality Management & Regulatory

☞ DSM

View: 174

Update day: 03-04-2024

Location: Aesch (BL) Basel-Landschaft BL

Category: Production / Operation

Industry: Chemical Manufacturing Research Services Biotechnology Research

Position: Associate

Job type: Full-time

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Job content

DSM – Bright Science. Brighter Living.™Royal DSM is a global science-based company active in health, nutrition and materials. By connecting its unique competences in life sciences and materials sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders simultaneously. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM and its associated companies deliver annual net sales of about 10 billion with approximately 25,000 employees. The company is listed on Euronext Amsterdam. More information can be found at www.dsm.com.DSM Pentapharm, part of the nutrition cluster of the DSM group has a long-standing tradition as an innovative and reliable supplier of active ingredients for the personal care, pharmaceutical and haemostasis diagnostics industries.For the site in Aesch (Basel, Switzerland) we are looking for a Head Quality Management and Regulatory (F/M). As member of the Leadership Team her/his responsibilities cover all functions related to Quality Control, Quality Assurance and Regulatory Affairs.Tasks & Responsibilities
  • 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 was and maintaining the quality budget
  • Being a member of Pentapharm Leadership Team
Qualification & Competences
  • 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
Location: CH-Aesch BLCondition: PermanentApplication & contact:Are you interested in this position? unisite ag is our recruitment partner. Please apply exclusievely by email to Ms. Andreea Borza, andreea.borza@unisite.ch. If you have any questions you can contact Ms. Borza under +41 78 741 80 61.Reference check procedures are part of the DSM Recruitment & Selection Process. You will be contacted when these references checks are required. .
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Deadline: 18-05-2024

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