9 days ago on novimmune.com

Quality Assurance Manager

NovImmune SA

  • Work region
  • Sector
  • Employment type
  • Position

 Please refer to JobSuchmaschine in your application

Quality Assurance Manager

Career Opportunity

Quality Assurance Manager

Novimmune SA is a drug discovery and development company located in Plan-les-Ouates and Basel, Switzerland, that focuses on developing therapeutic monoclonal antibodies for inflammatory diseases and immune-related disorders. The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets. Each of these portfolio products has the potential of becoming a medicine for multiple medical conditions due to the intrinsic mechanism of action. Five of these compounds are currently in early clinical development with the three most advanced in clinical Phase II. The company has also been purposefully targeting a number of orphan drug indications, with the express hope of eventually providing safe and effective treatment options to some of the often neglected populations suffering from rare diseases.

Novimmune is seeking a Quality Assurance Manager, based Plan-les-Ouates, who will report to the Global Head of QA.

Key responsibilities and accountabilities:
  • To act as QA representative and provide QA guidance to support the research & development organization in order to ensure compliance with GLP/GCLP
  • To review and approve quality documents (reports, protocols, study plans, procedures, working instructions). To prepare and issue procedures, specifications and certificates
  • To prepare, review and approve QA documents to support the release by the Qualified Person
  • To review & assess deviations, investigations, OOS, CAPAs, change control
  • To perform the GMP/GLP suppliers qualification, audits and ensure QA oversight on GLP/GMP activities. Setting up and maintaining the Quality Agreements
  • To implement and manage the QA systems, Documents system, Deviations, Change Control, Internal Audits, Inspection, CAPAs, Training
  • To implement Annual Product Review
  • To supervise, coach and train the QA team
  • To support the Inspection Readiness program. To facilitate the elaboration of CAPAs and ensure tracking and reporting
Skills and competencies:
  • Bachelor degree in biological sciences, chemistry, or related field
  • More than 5 years active experience in Quality in regulated pharmaceutical or biotechnological environment
  • Experience in biologics products development, manufacturing and in aseptic environment
  • Experience in managing team
  • Practical experience in conducting audits of GMP suppliers, sponsor, prepare sponsor and investigation sites for EU and FDA Regulatory Inspections
  • Ability to work effectively in team, and work independently and in multi-cultural environment
  • Ability to take pragmatic approach to problem solving
Additional requirements:
  • Good verbal and written communication in English and in French and interpersonal skills
  • Practical knowledge of Computer system validation
  • Ability to travel 10%, within EU and Internationally
  • Swiss resident or EU national

If your profile matches the above description, and if you are available at short-notice, please send us your CV and motivation letter in English with reference QAM to the following email address hr-recruitment@novimmune.com