Quality Risk Analyst

RoslinCT; Dalkeith; On-site; GBP 40,000 - 60,000; Full time

Job summary

A global contract development and manufacturing organisation seeking a Quality Risk Analyst to manage quality risk activities. The role involves leading risk assessments, developing risk registers and ensuring compliance with quality systems. Ideal candidates have a background in pharmaceuticals or a related field and will contribute to innovative therapies that improve lives.

Benefits

31 days annual leave plus public holidays

Generous salary package

Private healthcare

Company pension scheme

Qualifications

• Experience in a pharmaceutical GMP setting, ideally in commercial manufacturing.
• Proven experience in Quality Risk Management and strong hands-on experience.
• Solid knowledge of GMP and regulatory frameworks (MHRA, EMA, FDA).

Responsibilities

• Lead and coordinate quality risk management activities across the business.
• Define, deploy, and evolve the Quality Risk Management processes.
• Work cross-functionally to identify risks and influence strategic decisions.

Skills

Analytical skills

Effective communication

Education

Degree in Biology, Chemistry or Pharmacy

Tools

Microsoft Office

Job description

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RoslinCT is a global CDMO focused on Advanced Cell and Gene Therapies. It was established in 2006, built upon the ground-breaking cloning technology of Dolly the Sheep. RoslinCT is one of the first to produce clinical-grade human pluripotent stem cells and developed the first CRISPR-edited cell therapy product for a major inherited disorder, taking it from early development to commercialization.

Quality Risk Analyst

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!

• 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 [emailprotected] . We’re here to assist and make things as smooth as possible for you.