The company is creating cutting – edge therapies to help change people’s lives in their state-of-the-art GMP manufacturing facility in Edinburgh.
The Role:
You will be responsible for providing oversight and guidance to the Quality Department to achieve both department and business objectives. You will be reporting to Head of Quality.
Key Responsibilities:
- Ensure effective systems and processes are established and maintained to enable QP batch release
- Ensure systems are in place to maintain visibility and awareness of changes in legislation and guidelines, recommending areas for action and implementing change as required.
- Maintenance and continuous improvement of the company’s QMS to ensure full compliance with the UK, EU and US regulations and legislation for ATMP manufacture, including compliance with HTA.
- Ensures relevant performance metrics for Quality are established and reviewed, recommending areas for improvement.
- Liaises with clients and third parties to resolve quality related matters.
- Provision of advice to the Development, MSAT and Regulatory teams on topics concerning Quality and Licensing.
- Leads and develops an effective and motivated team of professionals on a range of activities ensuring the teams are managed effectively.
- Recruits, selects and develops individuals as per current and future organisational requirements as the business grows.
- Ensures the training needs of Quality team members are met.
- Coaches and develops team members to help them meet both their career and personal development goals ensuring a cohesive, productive and highly motivated working environment.
Experience:
- You will have a Life Science degree and line management experience in Quality in GMP manufacturing environment working within sterile manufacturing particularly with cell – based processing
- You must have experience in leading a team and training QA and Senior QA Officers accordingly
- You would ideally have experience working with quality management systems and compliant with FDA, UK, EU regulations