Head of Quality Assurance - Production

Real Staffing; Oxford; On-site; GBP 70,000 - 110,000; Full time

Job summary

A leading company is seeking a Head of Quality Assurance - Production in Oxford. The successful candidate will oversee quality assurance processes, ensuring compliance with international standards and regulatory requirements in key markets including the EU, UK, and the US. Candidates must have strong regulatory experience and be fluent in Mandarin or Cantonese and English.

Qualifications

• Fluency in Mandarin or Cantonese & English is required.
• Experience in CMC/quality assurance and regulatory compliance in Cell/Gene Therapy preferred.

Responsibilities

• Ensure that transferring products meet manufacturing and regulatory requirements.
• Develop and maintain a robust quality assurance system.
• Manage relationships with clients across geographies.
• Support biologics CMC regulatory submissions.

Skills

Regulatory Compliance

Quality Management

Audit and Inspection

Risk Assessment

Continuous Improvement

Education

Degree in relevant field or equivalent practical track record

Job description

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Head of Quality Assurance - Production, Oxford

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Client:

Real Staffing

Location:

Oxford, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

c7db65967d33

Job Views:

5

Posted:

02.06.2025

Expiry Date:

17.07.2025

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Job Description:

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

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