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- Tasks: Lead quality assurance in production, ensuring compliance and optimising team workflows.
- Company: Real Staffing is a dynamic recruitment agency focused on the pharma and biotech sectors.
- Benefits: Flexible location options, competitive salary, and opportunities for professional growth.
- Why this job: Join a forward-thinking team making a real impact in global health and innovation.
- Qualifications: Degree or equivalent experience in quality assurance; fluency in Mandarin or Cantonese and English required.
- Other info: Experience in regulatory submissions and a passion for continuous improvement are highly valued.
The predicted salary is between 43200 - 72000 £ per year.
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 to 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
Additional 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 Mandarin or Cantonese & English
Head of Quality Assurance - Production employer: Real Staffing
Contact Detail:
Real Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Quality Assurance - Production
✨Tip Number 1
Familiarise yourself with the latest regulatory standards and quality assurance practices in the pharma and biotech sectors. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the industry, especially those who have experience in CDMO manufacturing and quality assurance. Attend relevant conferences or webinars to make connections that could lead to valuable insights and potential referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed quality assurance processes in previous roles. Highlight your experience with regulatory submissions and compliance, as these are crucial for the position.
✨Tip Number 4
If you speak Mandarin or Cantonese, be sure to emphasise this skill during your interactions. Fluency in these languages can set you apart from other candidates and is particularly valuable given the global nature of the role.
We think you need these skills to ace Head of Quality Assurance - Production
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality assurance, regulatory compliance, and management roles within the pharma or biotech sectors. Use specific examples that demonstrate your expertise in these areas.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality assurance and how your skills align with the responsibilities outlined in the job description. Mention your fluency in Mandarin or Cantonese and English, as this is a key requirement.
Highlight Relevant Achievements: When detailing your work experience, focus on achievements that relate to regulatory submissions, audit and inspection processes, and continuous improvement initiatives. Quantify your successes where possible to make a stronger impact.
Showcase Your Knowledge of Regulations: Demonstrate your understanding of international regulatory standards and market trends, particularly in China, the EU, UK, and US. This will show that you are well-prepared to handle the challenges of the role.
How to prepare for a job interview at Real Staffing
✨Understand Regulatory Standards
Familiarise yourself with the regulatory requirements in China, the EU, UK, and the US. Be prepared to discuss how you have ensured compliance in previous roles, as this will demonstrate your expertise in quality assurance.
✨Showcase Leadership Experience
As a management role, it's crucial to highlight your leadership skills. Prepare examples of how you've successfully led teams, managed projects, or improved processes in a QA or manufacturing environment.
✨Demonstrate Technical Knowledge
Be ready to discuss your experience with GMP requirements and how you've interfaced with technical teams. This will show that you have the necessary technical background to lead quality assurance effectively.
✨Prepare for Scenario Planning Questions
Expect questions about risk management and scenario planning. Think of specific instances where you've had to analyse options and make decisions under pressure, as this will illustrate your problem-solving abilities.
