AX-7179 Director, Quality Assurance, Europe (GMP)
Leadership role managing EU GMP clinical and commercial product activities in an area of unmet medical need through a period of rapid company growth. Exciting opportunity to build and lead an EU QA group in the mid-term.
- Exciting well-funded, entrepreneurial, specialist biotech
- Recent, key phase III data success in an area with unmet medical need
- Rapidly growing in Europe
- Excellent opportunity to play a key role in this company’s transition from development to commercial
- Opportunity to build and lead a EU QA group in the mid term
- Central London location with home based flexibility
- Travel 15% to 20%
This position will report to VP Quality Assurance and be responsible for ensuring that all manufacturing campaigns are performed in compliance with the company’s Global Quality Systems, FDA guidelines and regulations, and European guidance and country specific regulations.
Ensure European requirements for manufacture, control and supply of investigational and commercial products for European markets are identified and implemented in the Quality Management System, specifically for GMP QA in accordance with applicable regulatory requirements and company policies
Ensure all materials are manufactured and supplied under EU GMP conditions, act as company QA contact person for various manufacturing, packaging, labeling, and distribution activities with CMOs in the EU. Responsible for establishing EU based CMO’s and analytical testing sites.
Oversee EU clinical trial and commercial materials manufactured or packaged by CMOs including batch record review, release, and disposition associated with Qualified Person certifications; and closure of OOSs, OOTs, NCMRs, CAPAs and deviations for each lot of material manufactured.
Responsible for supporting internal and external audit plans and activities, and ensuring GMP-related Quality Systems are EU and/or country specific compliant
QUALIFICATIONS / EXPERIENCE REQUIRED:
Comprehensive experience working within the CMC quality environment in the pharmaceutical or biotechnology industry, with specific experience in GMP quality assurance, auditing and GMP regulations
Comprehensive understanding of EU QP requirements for batch testing and release for investigational and commercial pharmaceutical products
Comprehensive working knowledge of EU, US and key international regulations pertaining to GMP for investigational and commercial pharmaceutical products
Complete and thorough understanding of regulatory GMP compliance requirements for US FDA and the EU
Auditor training or certification
Prior experience in regulatory inspections
For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300.
To apply, please click the APPLY ONLINE button.
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