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Job type: Permanent

Discipline: Senior/Director & VP

Location: Switzerland

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.

#LI-JV2

#Quality

Salary:

Highly Competitive Salary

Location:

Philadelphia, USA

Proclinical is currently recruiting for a Vice President of Commercial Quality Assurance with a leading biopharmaceutical company located in Philadelphia, PA.

Author Jason Lawrence

Apply

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Manager/Senior Manager, Document Control (Study Archivist)

Salary:

Highly Competitive Salary

Location:

Stamford, USA

Proclinical is currently recruiting for a Manager/Senior Manager of Document Control with a leading biotechnology company located in Stamford, CT.

Author Matt Phelan

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Senior Director of R&D Quality Systems & Strategy

Salary:

Highly Competitive

Location:

Reykjavík, Iceland

Proclinical have a unique chance for you to join one of the leading pharmaceutical companies in the world as a Senior Director of R&D Quality Systems & Strategy.