Our client is a leader in the Gene Therapy sector, dedicated to delivering high-quality products/services to customers worldwide enabling Drug Developers to reach patients faster. With manufacturing capacity and a commitment to being compliant for clients from all geographies, they are seeking a Head of Quality Assurance - Production to join the team.
Working with the CTO/VP of Manufacturing and the wider CDMO team the chosen candidate will help optimise the way the team works via effective translation of topics related to manufacturing and Quality ensuring information is disseminated from Production to the teams and ultimately clients/markets.
As the Head of Quality Assurance - Production you will ensure that transferring products meet and exceed the manufacturing and regulatory requirements in China, the EU, UK, and the US. You will be responsible for developing and maintaining a robust quality assurance system that adheres to international standards and best practices.
This position can be based in a variety of locations owing the language skills required e.g. UK, US, China, Far East etc.
Responsibilities:
- Management role or expertise in pharma/biotech
- Regulatory submission, clinical approval or IND-enabling/approval experience
- QA / Manufacturing role
- Client relationships across geographies
- Ideally CDMO manufacturing/service agreement contracting/CRM
- Supporting biologics CMC regulatory submissions
- Ability to lead scenario planning, options analysis, risk management activities
- GMP requirements and interfacing with QA (Quality Assurance), technical teams, external collaborators highly desired
- Experience of planning and qualifying a new facility would be a plus
Responsibilities:
- Regulatory Compliance, Quality Management, Audit and Inspection, Risk Assessment, Training and Development, Documentation and Reporting, Continuous Improvement etc.
- Stay updated on regulatory changes and market trends in China, the EU, UK, and the US that may impact products
Qualifications/Skills:
- Either a degree in a relevant field or equivalent practical track record
- CMC/quality assurance and regulatory compliance in Cell/Gene Therapy or a mixture of these
- Fluency in either Mandarinor Cantonese & English
To find out more about Real, please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales