Senior Clinical QA Manager

My client is a growing biopharmaceutical company based in the French part of Switzerland looking to expand their quality team. Due to this growth my client is looking for a Senior Clinical QA Manager to join their team on a permanent contract based near Lausanne.

Your Responsibilities

  • Plan, schedule and conduct audits of Clinical Investigator Sites, Vendors, Partners/affiliates and Clinical submission documents.
  • Coordinate responses and corrective/preventative actions from audit findings.
  • Provide GCP advice and support to Clinical Development/Operations functions and other relevant functions as assigned.
  • Stay abreast of EU clinical trial requirements, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the EU and other regions, as appropriate.
  • Assist in the review and revision of Clinical Development and QA SOPs.
  • Conduct GCP training
  • Alert Global R&D QA GCP/PhV Management of internal and external GCP compliance and clinical trial issues in a timely manner.
  • Be knowledgeable and be able to understand advanced operational, scientific and/or clinical research areas.
  • Provide support for regulatory authority inspections including conducting pre-inspection audits and inspection readiness activities as assigned.
  • Assist with the management of QA consultants performing audits
  • Experience in Quality for Pharmacovigilance and/or EU country operations would be an asset

Your Profile

  • Bachelor’s degree
  • At least 5 years’ experience with GCP audits of CRO’s and investigator sites.
  • Able to travel up to 30% at international level
  • Strong written and oral communication skills.

For more information, feel free to contact : Noémie Oliva: noliva@axepta.com

Noemie OLIVA

Noemie OLIVA

Team leader & Recruitment Manager Life Sciences

Morgane CAYUELA

Morgane CAYUELA

Life Sciences Recruitment Specialist

Marine DOLLAT

Marine DOLLAT

Life Sciences Recruitment Specialist

Senior Clinical QA Manager

Sep 17, 2021Senior Clinical QA ManagerLausanne Full Time Permanent Job noliva@axepta.com Life Sciences

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