Head of Quality Assurance, clinical trials, Paris

A Paris-based pharmaceutical company, specializing in the research, development and commercialization of tyrosine kinase inhibitors, a new class of targeted therapeutic molecules, is looking for a Head of Quality Assurance, member of the executive committee and reporting to the company’s top management.
The company is leading an important clinical development program in oncology, neurology and inflammatory diseases, with 20 Phase 1 and 2 clinical studies in France and 13 Phase 3 clinical studies in 30 countries.

Job functions
Develop and implement quality systems for the clinical research, product development and commercial launch functions, based on current best practices in industry
Guarantee the company’s quality system
Provide leadership and guidance during EMA and FDA health inspections
Prepare and organize responses to regulatory agencies
Manage the auditing function for the company by developing and managing detailed audit plans for all involved partners
Member of the company’s executive committee

10 or more years experience in a technical role in quality assurance, manufacturing, analytical testing or engineering with at least 5 years in a related management role
Significant background acquired in pharmaceutical company
Significant experience of EMA and FDA inspections
BS in Engineering, Chemistry, Biological Sciences or related field with an education or training in cell culture and gene therapy a plus
ASQ Auditor certification, ASQ Quality Engineer certification preferred
Fluent in English
Proficient in MS Word, Excel, Power Point
Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities

Additional informations
Permanent position available immediately
Position based in Paris
Package to define according to experience, range : 100 – 150K€

Please submit your CV to inna.uvarova@arjinexecutivesearch.com

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