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Job type: Permanent

Discipline: Good Clinical Practice (GCP)

Location: Switzerland

A worldwide biotechnology company situated in Geneva and operating in over 70 markets worldwide is looking for a Director to Quality Management Development Projects.

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
Define KQIs/KCIs, collect data for periodic management review to identify Risks and mitigate

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
Strong understanding and interpretation of GMPs and best quality practices with regards to biotech manufacturing processes and control
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

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

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