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- Tasks: Lead and motivate a team while ensuring compliance with complex regulations in cell and gene therapy.
- Company: Join a pioneering organization specializing in cell therapy and genetic testing.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and development.
- Why this job: Make a real impact in healthcare by ensuring quality and compliance in innovative therapies.
- Qualifications: Must have knowledge of HTA, ISO 15189, FACT, and JACIE regulations.
- Other info: This role offers a chance to influence the future of medical treatments.
The predicted salary is between 43200 - 72000 £ per year.
Quality Assurance Manager – Cell and Gene Therapy 60-100%
About the Company – This organisation specialises in Cell Therapy, blood products, genetic sequencing/testing and processing.
About the Role – Provide expert advice, to all levels of the organisation including members of the leadership forum, on the complex, multi-stranded regulations relating to our laboratory services. To lead and motivate the Quality Managers to achieve individual and team performance objectives and empower people by delegating responsibility appropriately. This includes oversight over the QMS workloads for the team and ensuring resource is allocated to meet the demands of the service delivery function and to avoid any backlogs or delays in the processes (for e.g. quality team approvals for the QMS, quality reviews for product release processes, quality reviews for documents and quality incidents). Proactively plan for changes in this environment. Proactively monitor regulatory changes in the environment and ensure the organisations on-going compliance with legislation and accreditation requirements, and voluntary best practice codes of conduct.
Responsibilities –
- Provide expert advice on complex regulations
- Lead and motivate Quality Managers
- Ensure resource allocation for service delivery
- Proactively plan for changes
- Monitor regulatory changes
- Oversight over the QMS workloads for the team and ensuring resource is allocated to meet the demands of the service delivery function and to avoid any backlogs or delays in the processes
- Quality reviews for product release processes, quality reviews
Required Skills – Knowledge of the below regulations is compulsory:
- Human Tissue Authority (HTA)
- ISO 15189
- FACT
- JACIE
If you’re interested in the role above, please reach out to
Quality Assurance Manager Cell and Gene Therapy 60-100% employer: BioTalent
Contact Detail:
BioTalent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Manager Cell and Gene Therapy 60-100%
✨Tip Number 1
Familiarize yourself with the specific regulations mentioned in the job description, such as HTA, ISO 15189, FACT, and JACIE. Being able to discuss these regulations confidently during your interview will demonstrate your expertise and commitment to the role.
✨Tip Number 2
Showcase your leadership skills by preparing examples of how you've successfully led teams in the past. Highlight instances where you motivated team members and delegated responsibilities effectively, as this is a key aspect of the role.
✨Tip Number 3
Stay updated on the latest trends and changes in the regulatory landscape related to cell and gene therapy. Being proactive about these changes will not only help you in the role but also impress the hiring team with your forward-thinking approach.
✨Tip Number 4
Prepare to discuss your experience with Quality Management Systems (QMS) and how you've managed workloads in previous roles. Providing concrete examples of how you've avoided backlogs or delays will be crucial in demonstrating your fit for this position.
We think you need these skills to ace Quality Assurance Manager Cell and Gene Therapy 60-100%
Some tips for your application 🫡
Understand the Role: Make sure you fully understand the responsibilities and requirements of the Quality Assurance Manager position. Highlight your experience with regulations like HTA, ISO 15189, FACT, and JACIE in your application.
Tailor Your CV: Customize your CV to reflect your relevant experience in quality assurance and regulatory compliance. Use specific examples that demonstrate your ability to lead teams and manage QMS workloads effectively.
Craft a Compelling Cover Letter: Write a cover letter that showcases your expertise in cell and gene therapy regulations. Explain how your leadership style aligns with motivating teams and achieving performance objectives.
Highlight Proactive Planning Skills: Emphasize your ability to proactively monitor regulatory changes and plan for compliance. Provide examples of how you've successfully navigated complex regulatory environments in the past.
How to prepare for a job interview at BioTalent
✨Show Your Regulatory Knowledge
Make sure to brush up on the Human Tissue Authority (HTA), ISO 15189, FACT, and JACIE regulations. Be prepared to discuss how your knowledge can help the organization maintain compliance and improve their quality management systems.
✨Demonstrate Leadership Skills
Since the role involves leading and motivating Quality Managers, be ready to share examples of how you've successfully led teams in the past. Highlight your ability to delegate responsibilities effectively and empower team members.
✨Discuss Proactive Planning
Prepare to talk about your experience with proactive planning in a regulatory environment. Share specific instances where you anticipated changes and how you adapted processes to ensure compliance and efficiency.
✨Emphasize Problem-Solving Abilities
The role requires oversight of QMS workloads and avoiding backlogs. Be ready to discuss challenges you've faced in similar situations and how you resolved them, showcasing your analytical and problem-solving skills.
