At a Glance
- Tasks: Lead the Quality Operations team to ensure compliance and operational excellence in cell therapy.
- Company: Join RoslinCT, a pioneering organisation in cell and gene therapy that transforms lives.
- Benefits: Enjoy 31 days of leave, private healthcare, and flexible benefits like retail discounts.
- Why this job: Be part of a rapidly growing company making a real impact in healthcare.
- Qualifications: Extensive experience in Quality Management within GMP environments and a relevant life science degree required.
- Other info: We value inclusivity and welcome applications from everyone, ensuring a fair recruitment process.
The predicted salary is between 54000 - 84000 £ per year.
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.
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 jobs@roslinct.com. We’re here to assist and make things as smooth as possible for you.
Senior Quality Operations Manager employer: RoslinCT
Contact Detail:
RoslinCT Recruiting Team
jobs@roslinct.com
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Operations Manager
✨Tip Number 1
Familiarise yourself with the latest GMP regulations and guidelines, especially those related to cell and gene therapy. This knowledge will not only help you in interviews but also demonstrate your commitment to quality operations.
✨Tip Number 2
Network with professionals in the cell therapy and biopharmaceutical sectors. Attend industry events or webinars to connect with potential colleagues at RoslinCT, which can give you insights into their culture and expectations.
✨Tip Number 3
Prepare to discuss specific examples of how you've led quality teams and improved processes in previous roles. Highlighting your leadership experience and results-driven mindset will resonate well with the hiring team.
✨Tip Number 4
Research RoslinCT's recent projects and achievements in cell and gene therapy. Being able to reference these during your discussions will show your genuine interest in the company and its mission.
We think you need these skills to ace Senior Quality Operations Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive experience in Quality Management, particularly within GMP-regulated environments. Emphasise your leadership skills and any specific achievements related to quality assurance in cell therapy or biological products.
Craft a Compelling Cover Letter: In your cover letter, express your passion for the role and the company. Discuss how your background aligns with RoslinCT's mission and values, and provide examples of how you've successfully led teams and improved quality operations in previous roles.
Highlight Relevant Qualifications: Clearly state your qualifications, including your honours degree in a relevant life science discipline. Mention any additional certifications or training that relate to quality management systems or GMP compliance.
Showcase Soft Skills: RoslinCT values strong interpersonal and communication skills. In your application, provide examples of how you've effectively managed stakeholders and fostered a positive team culture, demonstrating your emotional intelligence and leadership presence.
How to prepare for a job interview at RoslinCT
✨Showcase Your Leadership Skills
As a Senior Quality Operations Manager, you'll need to demonstrate your ability to lead and develop a high-performing team. Prepare examples of how you've successfully managed teams in the past, focusing on your leadership style and the outcomes achieved.
✨Understand GMP Regulations Thoroughly
Given the role's focus on compliance with GMP requirements, it's crucial to have a solid understanding of these regulations. Brush up on UK, EU, and US guidelines related to ATMP and stem cell manufacturing, and be ready to discuss how you've applied them in previous roles.
✨Prepare for Technical Questions
Expect to face technical questions regarding quality assurance processes and sterile manufacturing. Review key concepts related to cell therapies and biological products, and be prepared to explain how you would handle specific quality challenges.
✨Demonstrate Strong Communication Skills
Effective communication is vital in this role, especially when presenting technical information to diverse audiences. Practice articulating complex ideas clearly and concisely, and think of examples where your communication skills led to successful stakeholder management.