Director, QM Development Projects job in Lausanne, Switzerland

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

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Phone Number*

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Job type: Permanent

Discipline: Senior/Director & VP

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

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.

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