Director, QM Development Projects

Highly Competitive
  1. Permanent
  2. Senior/Director & VP
  3. Switzerland
Lausanne, Switzerland
Posting date: 21 Sep 2020

A multinational pharmaceutical organisation is looking for a dynamic Director of Quality Management Development Projects. This role will include leadership and oversight to the development to ensure compliance.

Job Responsibilities

  • Manage GMP quality oversight (qualification, approval, monitoring) of C(D)MOs and suppliers of starting materials by planning and executing vendor audits, including monitoring of CAPA progresses till completion
  • Negotiate, establish and maintain quality agreements
  • Perform Gate Reviews for PPQ readiness
  • Ensure Inspection readiness of all GMP Vendors
  • Manage internal and external Change Controls, Deviations, Events, CAPAs, etc., related to all activities associated to a program
  • Manage GMP compliance during Tech Transfer activities by reviewing, approving, as applicable, protocols, plans and reports (e.g. development, validation)
  • Identify the risks and establish appropriate mitigation plan
  • Responsible to review and approve all GMP documents needed for submission
  • Bio similarity data management and Integrity
  • Responsible for GMP/GDP quality in FKSBS sponsored clinical studies

Skills and Requirements

  • A BA/BS, MA/MS or PhD in a scientific discipline or related field
  • Minimum 10 years' experience in a Quality function with increasing levels of responsibility in the biopharmaceutical industry
  • Experience with regulatory agencies such as the FDA, EMA, etc.
  • Proven success in CMO quality management for clinical products
  • Excellent communication skills in English, both written and oral, knowledge of French and/or German is an asset
  • Decision Making & Problem Solving

To Apply

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.