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For Companies At a Glance
- Tasks: Coordinate quality risk management and develop risk strategies across departments.
- Company: Join RoslinCT, a leader in cell and gene therapy transforming lives with innovative science.
- Benefits: Enjoy 31 days annual leave, private healthcare, flexible benefits, and a competitive salary package.
- Why this job: Be part of a rapidly growing company making a real impact in healthcare.
- Qualifications: Degree in Biology, Chemistry or Pharmacy; experience in pharmaceutical quality and risk analysis required.
- Other info: We value inclusivity and welcome applications from everyone, ensuring a fair recruitment process.
The predicted salary is between 36000 - 60000 £ per year.
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.
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 Quality Risk Analyst to join our growing Quality team here at RoslinCT. You will be responsible for coordinating quality risk management across departments in accordance with ICH guideline Q9. This position will support science-based decision-making and will develop and maintain an interactive risk register which highlights key risks and mitigation strategies for the leadership team. Define, deploy, and review the quality risk management process, ensuring resources are in place. Develop and maintain Risk Management policies, procedures, and methodologies. Lead and conduct detailed risk assessments, creating contingency plans to minimise crisis impact. Monitor and report on risk management performance metrics. Apply tools like FMEA, FMECA, FTA, and statistical analysis for risk assessment. Facilitate stakeholder meetings to discuss risk status and mitigation. Tracks industry trends to adapt risk strategies accordingly. Partner with internal and external stakeholders, including customers and regulatory bodies.
About You
- Experience in a Pharmaceutical Quality department in a commercial manufacturing environment, preferably Contract Manufacturing.
- Proven work experience as a Risk Analyst or similar position.
- A clear understanding of GMP, regulatory and quality management as applied to Advanced Therapy Medicinal Products.
- Competence in reporting and presenting internally/externally (MHRA visits, customer visits, training, auditing).
- Demonstrable ability to make decisions, analyse information in a logical manner and be able to prepare coherent investigative and/or technical reports.
- Excellent knowledge of risk analysis methodologies and tools.
- Experience in leading and engaging a team as well as strong influencing, motivational, and communication skills.
- Experience in data interpretation and analysis.
- Proficient in risk management software.
- Competent in computer packages including Microsoft Office and an electronic quality management package.
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 to 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.
Quality Risk Analyst employer: RoslinCT
Contact Detail:
RoslinCT Recruiting Team
jobs@roslinct.com
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Risk Analyst
✨Tip Number 1
Familiarise yourself with ICH guideline Q9, as this is crucial for the Quality Risk Analyst role. 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 who work in quality departments. Engaging with them can provide insights into the role and may even lead to referrals or recommendations.
✨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 will set you apart from other candidates.
✨Tip Number 4
Prepare to discuss your experience with data interpretation and analysis. Be ready to share specific examples of how you've used these skills in previous roles, as they are essential for the position at RoslinCT.
We think you need these skills to ace Quality Risk Analyst
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Quality Risk Analyst at RoslinCT. Familiarise yourself with key terms like ICH guideline Q9, FMEA, and GMP to demonstrate your knowledge in your application.
Tailor Your CV: Customise your CV to highlight relevant experience in pharmaceutical quality departments and risk analysis. Emphasise your understanding of regulatory requirements and any specific methodologies you've used in previous roles.
Craft a Compelling Application Form: When completing the application form, clearly articulate why you are interested in the role and what unique skills you bring. Use specific examples from your past experiences that align with the job description.
Proofread Your Documents: Before submitting your application, thoroughly proofread your CV and application form for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a Quality Risk Analyst.
How to prepare for a job interview at RoslinCT
✨Understand the Role and Responsibilities
Make sure you thoroughly understand the job description and the specific responsibilities of a Quality Risk Analyst. Familiarise yourself with ICH guideline Q9 and be prepared to discuss how you would apply it in practice.
✨Showcase Your Experience
Be ready to share examples from your previous roles that demonstrate your experience in risk analysis, particularly in a pharmaceutical quality department. Highlight any specific methodologies you've used, such as FMEA or statistical analysis.
✨Prepare for Technical Questions
Expect technical questions related to risk management tools and methodologies. Brush up on your knowledge of GMP, regulatory standards, and quality management as they pertain to Advanced Therapy Medicinal Products.
✨Demonstrate Communication Skills
Since the role involves facilitating stakeholder meetings and presenting reports, practice articulating your thoughts clearly and confidently. Be prepared to discuss how you would engage with both internal teams and external regulatory bodies.
