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Director, Quality Management Development Projects

Employer
Proclinical Staffing
Location
Lausanne, Switzerland / Switzerland
Salary
Negotiable
Start date
24 Sep 2020
Closing date
8 Oct 2020

Job Details

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.

#LI-JG1

#Quality

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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