Senior Quality Operations Manager
Location: Edinburgh BioQuarter and Shawfair, Dalkeith
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
- We are looking for a Senior Quality Operations Manager to join our growing Quality function here at RoslinCT.
- This position will be responsible for leading the Quality Operations team in overseeing the delivery of core Quality Assurance activities in line with GMP requirements.
- You will play a central part in ensuring operational excellence across batch documentation review, compliance with regulatory bodies, and support of key manufacturing timelines.
- Partner closely with production, project management, QC, and QP teams to ensure end-to-end quality compliance, resource planning, and continuous improvement.
- Deputise for the UK Head of Quality as required, providing reports to the senior leadership team and Qualified Persons, identifying QMS deficiencies and recommending corrective actions.
- Lead and develop a high-performing team of QA professionals across core Quality Operations activities.
- Oversee workload planning and capacity analysis to ensure sufficient Quality Operations resource availability for batch release timelines.
- Generate and monitor Key Performance Indicators (KPIs) for Quality Operations to identify areas for improvement and drive operational efficiency.
- Maintain and improve the Quality Management System to ensure full compliance with UK, EU, and US regulations related to ATMP and stem cell manufacturing, including MHRA, FDA, and HTA guidelines.
- Create and present batch release metrics and performance reports for quality governance meetings and the Quality Review Board.
- Monitor quality trends and lead improvement initiatives in collaboration with cross-functional teams.
- Ensure timely completion of Quality System activities, including deviations, investigations, CAPAs, and change controls.
- Manage customer complaints and serve as the primary Quality contact for clients.
- Provide Quality leadership in Cell Therapy Development, Tech Transfer, and major projects, ensuring timely QA input and approvals.
- Represent RoslinCT professionally in external meetings, audits, and industry events.
About you
- Extensive experience in a senior Quality Management role within a GMP-regulated environment.
- Proven leadership of a large Quality team, with the ability to drive team performance and improvement.
- In-depth knowledge of GMP principles and their application to cell therapy and biological products in both clinical and commercial settings.
- Strong understanding of sterile manufacturing processes, especially those involving cell-based therapies.
- A solid scientific foundation in biological systems; specific knowledge of cell therapies is highly desirable.
- Experience with Electronic Quality Management Systems.
- Outstanding organisation and planning skills, with the ability to deliver results under pressure.
- Strong interpersonal and communication skills, with the ability to present technical information clearly to both technical and non-technical audiences.
- Effective stakeholder and customer expectation management.
- High levels of accountability, initiative, and integrity.
- Positive leadership presence with emotional intelligence and self-awareness.
- Demonstrated success in creating a positive team culture and strong cross-functional relationships.
Qualifications
- Honours degree (or equivalent) in a relevant life science discipline.
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 explaining your interest in the role and what you would bring to RoslinCT.
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 [email protected]. We’re here to assist and make things as smooth as possible for you.
