Quality Manager Drug Substance


Reference Number: 895632-W
Type of placement: Permanent, Permanent
Location: Switzerland, North West


For one of our clients, a leading biopharmaceutical company, we are currently looking for a Quality Manager Drug Substance. 

Main Responsibilities:

  • Provide GMP/GDP quality assurance expertise during development and later during commercialization of the company’s products
  • Perform GMP onsite audits at Contract Manufacturing Organizations (CMOs)
  • Preparation of GMP/GDP Agreements in collaboration with CMOs and the CMC team
  • Write, review, and/or approve internal SOP and other GMP/GDP related documentation
  • Ensure that medicinal products are designed, developed, manufactured and controlled according to quality standards
  • Establish a quality risk management approach in projects based on six sigma concepts to ensure that quality is understood and managed by all stakeholders throughout the product life cycle
  • Manage all required activities to support release of active ingredients, investigational medicinal products including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls
  • Notify management of potential quality and regulatory issues
  • For assigned projects, provide guidance on the resolution of complaints, testing issues, discrepancies and Out of Specifications, investigations and Corrective and Preventive Actions as needed
  • Support review and optimization of the company’s pharmaceutical quality system by establishing and preparing review of relevant Key Performance Indicators.

Qualifications and Experience:

  • Advanced University degree in Pharmacy, Chemistry or alternative technical/science university degree
  • Minimum of 5 years’ experience in different positions like pharmaceutical or chemical development, quality control, analytical development, chemical or pharmaceutical production or similar operational positions in the pharmaceutical industry
  • In addition, minimum of 3 years’ experience in quality assurance of drug substance
  • Excellent knowledge of GMPs and regulatory environments, ability to interpret and implement quality standards
  • Strong interpersonal and influencing skills
  • Excellent verbal and written communication skills in English
  • Ability to manage multiple tasks with competing priorities
  • Entrepreneurial mind set combined with cost consciousness
  • Relevant working/residency permit or Swiss/EU-Citizenship required