Project Manager Design Controls & DHF - Consultant

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.