Project Manager Design Controls & DHF - Consultant job in Paris, France

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Good Distribution Practice (GDP)

Location: France

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

Proclinical is seeking a Project Manager Desgin Controls & DHF - Consultant with a focus on Design Controls. This role is crucial in the development of a Biologics License Application (BLA) for an innovative biotech company. The successful candidate will manage Design Output/Verification remediation activities, ensure design verification testings are accurate and exhaustive, and actively support the establishment and review of Product Risk Management documentation.

Responsibilities:

Act as the Combination Product Project Manager to manage Design Output / Verification remediation activities
Ensure design verification testings are in line with current FDA and EMA requirements
Act as an interface between the Development Team and Design Control Team
Provide active support to the establishment and review of the Product Risk Management documentation
Participate in the review of Design Control section for BLA submission
Advise and involve in the continuous improvement of design control process through the SOPs

Key Skills and Requirements:

Ability to work independently and in a global team environment
Strong collaborative spirit and well-organised
Extensive Design Control experience and familiarity with both US FDA and EU EMA regulations
Experience in Combination Product (biologic) BLA submission and approval
Risk management skills and knowledge of ISO 14971:2019
Transversal project management skills
Good verbal and written communication skills
Experience in combination product (biologic)/medical device development
Knowledge of Pharmaceutical development ICH Q8 & QbD skills is a plus
Proficiency in English and French

If you are having difficulty in applying or if you have any questions, please contact Will Hitchcock on w.hitchcock@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.