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- Tasks: Coordinate quality risk management and develop risk strategies in a dynamic team.
- Company: Join RoslinCT, a leader in cell and gene therapy, transforming lives with innovative science.
- Benefits: Enjoy 31 days of leave, private healthcare, flexible benefits, and a competitive salary package.
- Why this job: Be part of a rapidly growing company making a real impact on people's lives.
- Qualifications: Degree in Biology, Chemistry or Pharmacy; experience in Pharmaceutical Quality preferred.
- Other info: We value inclusivity and welcome applications from everyone, ensuring a fair recruitment process.
The predicted salary is between 36000 - 60000 £ per year.
RoslinCT Edinburgh, Scotland, United Kingdom
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RoslinCT Edinburgh, Scotland, United Kingdom
3 days ago Be among the first 25 applicants
Join to apply for the Quality Risk Analyst role at RoslinCT
Location: Edinburgh BioQuarter/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
In this critical role, you’ll lead and coordinate quality risk management activities across the business, helping us anticipate, assess, and control risks associated with manufacturing, quality systems, and compliance.
Your responsibilities will include:
- Define, deploy, and evolve RoslinCT\’s Quality Risk Management processes.
- Lead risk assessments using tools such as FMEA, FMECA, FTA, and statistical methods.
- Develop and maintain an interactive, real-time risk register for visibility at the senior leadership level.
- Work cross-functionally to identify risks, define mitigations, and influence strategic decisions.
- Create and update risk management policies, SOPs, and training materials.
- Partner with manufacturing, QC, QA, and regulatory colleagues to ensure alignment across departments.
- Monitor industry trends, regulatory expectations, and internal metrics to adapt the risk strategy accordingly.
- Represent Quality Risk Management in audits, regulatory inspections, and customer reviews.
What We\’re Looking For
To be successful in this role, you must have a background in pharmaceutical quality systems (ideally in an advanced therapy or sterile product environment), and strong hands-on experience with formal risk methodologies.
Essential experience and skills:
- Experience in a pharmaceutical GMP setting, ideally in commercial manufacturing or contracting manufacturing (CMO/CDMO).
- Proven experience in Quality Risk Management, including leading formal risk assessments.
- Solid knowledge of GMP and regulatory frameworks (e.g. MHRA, EMA, FDA).
- Proficient in applying structured risk tools like FMEA, FMECA, FTA.
- Strong analytical and reporting skills, including data interpretation and visualisation.
- Effective communicator, comfortable presenting to senior leadership, auditors, and regulators.
- Familiar with QMS platforms and risk software; confident in Microsoft Office.
- Prior involvement in building or scaling risk frameworks within a GMP-regulated setting is preferable.
Qualifications:
- The successful candidate will be educated to degree level (or equivalent qualification) in Biology, Chemistry or Pharmacy.
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 what you could bring o the role at 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.
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Quality Risk Analyst employer: RoslinCT
Contact Detail:
RoslinCT Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Risk Analyst
✨Tip Number 1
Familiarise yourself with ICH guideline Q9 and other relevant regulatory frameworks. Understanding these guidelines will not only help you in interviews but also demonstrate your commitment to quality risk management.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those working in quality risk management. Attend industry events or join online forums to gain insights and potentially get referrals for the Quality Risk Analyst position.
✨Tip Number 3
Brush up on your knowledge of risk analysis methodologies like FMEA and FTA. Being able to discuss these tools confidently during your interview can set you apart from other candidates.
✨Tip Number 4
Prepare to showcase your experience in leading teams and facilitating stakeholder meetings. Think of specific examples where you've successfully managed risks or improved processes, as this will highlight your suitability for the role.
We think you need these skills to ace Quality Risk Analyst
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality risk management and any specific methodologies mentioned in the job description, such as FMEA or statistical analysis. Use keywords from the job listing to ensure your application stands out.
Craft a Compelling Cover Letter: In your cover letter, express your passion for the role and the company. Discuss how your background in pharmaceutical quality and risk analysis aligns with RoslinCT's mission and values. Be specific about what you can bring to the team.
Showcase Relevant Skills: Emphasise your skills in risk assessment, data interpretation, and communication. Provide examples of how you've successfully led teams or projects in the past, particularly in a commercial manufacturing environment.
Follow Application Instructions: When applying, ensure you complete the short application form thoroughly. Clearly articulate why you are interested in the position and how your qualifications make you a suitable candidate for the Quality Risk Analyst role at RoslinCT.
How to prepare for a job interview at RoslinCT
✨Understand Quality Risk Management
Make sure you have a solid grasp of quality risk management principles, especially ICH guideline Q9. Be prepared to discuss how you've applied these concepts in previous roles and how they can be beneficial in the position at RoslinCT.
✨Showcase Your Analytical Skills
As a Quality Risk Analyst, your ability to analyse data and make informed decisions is crucial. Bring examples of past experiences where you've successfully conducted risk assessments or used tools like FMEA or FTA to demonstrate your analytical prowess.
✨Prepare for Stakeholder Engagement
Since the role involves facilitating stakeholder meetings, think about how you can effectively communicate risk statuses and mitigation strategies. Prepare to share examples of how you've engaged with stakeholders in the past and the outcomes of those interactions.
✨Familiarise Yourself with Regulatory Standards
Having a clear understanding of GMP and regulatory requirements is essential. Brush up on relevant regulations related to Advanced Therapy Medicinal Products and be ready to discuss how you would ensure compliance in your role.
