Senior Quality Manager - Lausanne

For our client a development stage oncology company, we are looking for a Senior Quality Manager.

The company focuses on the identification, license acquisition and development of products from preclinical to phase 2 in oncology. The Senior Quality Manager will be responsible for the Quality Management System (QMS) and lead QA activities. They will provide Quality direction, training, and support to the company team and collaborate with CROs, CMOs and contract laboratories to ensure quality and GxP compliance is met.


Main duties and responsibilities

  • Build QRM plans and identify risk mitigation plans

  • Execute the risk management plan to support company activities

  • Ensure business activities are conducted in compliance with the regulations and standards applicable to Onward business

  • Develop, implement, and maintain the organization’s QMS

  • Propose and/or review policies, SOPs, and other quality documentation

  • Promote quality assurance principles across the company and ensure that all aspects of the QMS are understood, implemented, and maintained by company employees·

  • Track key performance metrics and trending of quality systems

  • Support implementation of quality systems and processes, including tracking of all investigations, deviations, and Corrective and Preventative Actions (CAPAs)

  • Assess the need (or not) to be certified, and recommend the corresponding action plan when necessary

  • Review all investigations and follow up with CAPAs

  • Participate in vendor management evaluation

  • Review and approve quality agreements with CMOs, CROs and contract laboratories.

  • Provide quality oversight of preclinical and clinical development programs including subcontracted activities (external CRO, CMO, contracted laboratories)

  • Contribute to the preparation of regulatory dossiers

  • Manage internal and external quality related audits for the Company

Qualifications and experience

  • Bachelor’s degree in science, pharmacy, or engineering. Advanced studies in quality management, or related field would be a plus

  • A minimum of 5 years of experience in quality assurance, preferably in the bio/pharmaceutical industry

  • Involved in continuous improvement activities

  • Fluent in French and English. German would be a plus

Skills

  • Analytical, problem-solving, and critical-thinking skills

  • Organized, rigorous and precise

  • Team-spirited, sense of service and excellent communication skills allowing him/her to maintain excellent relations with his/her colleagues

  • “Startup mindset”: taste for innovation, flexible and adaptable

  • Expertise in Microsoft office computer software

Please contact recruitment@consultantsinscience.com for a full job description.