Quality Assurance Supervisor - QMS

Quality Assurance Supervisor - QMS

Location: Edinburgh BioQuarter

Who are we?

We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people's lives.

Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

Find out more about what we do here !

Why join us?

• The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
• A generous salary package - we reward our people at the level they deserve.
• 31 days of annual leave, plus 4 public holidays which increases with tenure.
• A competitive company pension scheme to help you save for the future.
• Group Life Cover - you are automatically covered for three times your basic salary to give you and your family peace of mind.
• Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
• Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

Your new role

• An exciting opportunity for a Quality Assurance Supervisor - QMS to join our team.
• You will be primarily responsible for supporting the Quality Improvement Manager to continually improve RoslinCT's Quality Management Systems (QMS), ensuring compliance with UK and EU regulations for stem cell lines and cellular therapies.
• Develop and delivering training in all aspects of Quality Management and GMP.
• Ensure systems are in place and are followed for the reporting and investigation of quality related incidents, defective products or adverse events and for the control of critical documents.
• Support with Risk Management Procedures and ensure risk assessments are performed.
• Certify that department equipment and processes are subject to validation, and that documentation used in validations are approved.
• Make certain that effective change control procedures are in place for changes to the manufacturing process, GMP activities and other areas of the business when necessary.
• Assist the QA Manager with leading audit programs in all internal RoslinCT operations, and where appropriate external suppliers used in the processes of RoslinCT.
• When required, deputise for the QA Manager by providing regular reports to RoslinCT's management team, identifying deficiencies in the QMS and advising on necessary corrective action.

About you

• GMP, regulatory and accreditation systems and quality management experience.
• Exceptional leadership skills, with the ability to learn and share knowledge with the wider and management teams.
• Competent in reporting and presenting internally / externally.
• Strong decision making and analytical skills.
• Effective communicator, with the ability to express this orally and in written form.
• Excellent attention to detail, with the continued desire to support the development and improvement of processes.
• Working knowledge in computer packages including Microsoft Office and QPulse.

Qualifications

• An honours degree in a relevant Life Science discipline or equivalent qualification.

Next Steps

If this sounds like you, then please hit 'Apply' now. We will ask you to upload your CV and complete a short application form detailing why you are interested and why we should hire you.

At RoslinCT, we're all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they're valued and encouraged to be themselves, whether they're our employees, customers, or partners.

We take pride in being an equal opportunity employer. We treat all applicants fairly and don't discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms.

If you've got any specific needs or concerns regarding accessibility during the recruitment process, don't hesitate to reach out to us at . We're here to assist and make things as smooth as possible for you.