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Head of Quality Assurance - Production, Oxford
Client: Real Staffing
Location: Oxford, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: c7db65967d33
Job Views: 7
Posted: 05.05.2025
Expiry Date: 19.06.2025
Job Description:
Working with the CTO/VP of Manufacturing and the wider CDMO team, the chosen candidate will help optimize team workflows through effective translation of manufacturing and Quality topics, ensuring information dissemination from Production to teams and ultimately clients/markets.
As the Head of Quality Assurance - Production, you will ensure that transferred products meet and exceed manufacturing and regulatory requirements across China, the EU, UK, and the US. You will develop and maintain a robust quality assurance system aligned with international standards and best practices.
This position can be based in various locations, depending on language skills, e.g., UK, US, China, Far East, etc.
Responsibilities:
* Management or expertise in pharma/biotech
* Regulatory submissions, clinical approvals, or IND-enabling/approval experience
* QA / Manufacturing roles
* Client relationships across geographies
* Experience with CDMO manufacturing/service agreement contracting/CRM
* Supporting biologics CMC regulatory submissions
* Leading scenario planning, options analysis, risk management activities
* GMP requirements, interfacing with QA, technical teams, external collaborators
* Experience in planning and qualifying new facilities is a plus
Additional Responsibilities:
* Regulatory compliance, quality management, audits and inspections, risk assessment, training, documentation, continuous improvement
* Staying updated on regulatory changes and market trends in China, the EU, UK, and the US that impact products
Qualifications/Skills:
* A relevant degree or equivalent practical experience
* CMC/Quality assurance and regulatory compliance experience in Cell/Gene Therapy or related fields
* Fluency in Mandarin or Cantonese & English
Real Staffing, a trading division of SThree Partnership LLP, acts as an Employment Business regarding this vacancy. Registered office: 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom. Partnership Number: OC387148, England and Wales.
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