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- Tasks: Lead quality risk management processes and conduct detailed risk assessments.
- Company: Innovative biotechnology firm in Edinburgh with a focus on advanced therapies.
- Benefits: Competitive salary, career growth, and the chance to influence quality strategy.
- Other info: Collaborative culture with opportunities for continuous improvement and training.
- Why this job: Make a real impact on quality standards and support business growth.
- Qualifications: Degree in Biology, Chemistry, or related field; experience in quality environments.
The predicted salary is between 36000 - 60000 £ per year.
Quality Risk Analyst – Edinburgh
An exciting opportunity has arisen for an experienced Quality Risk Analyst to join a leading organisation within the biotechnology manufacturing sector. This role is based in Edinburgh and offers the chance to make a significant impact on quality risk management strategy and processes across the business.
About the Role
As a Quality Risk Analyst, you will take ownership of the organisation’s quality risk management processes in line with ICH Q9 guidelines. You will develop and maintain a robust risk management framework, lead cross-functional risk assessments, and provide clear visibility of risk status to senior leadership. This role plays a key part in ensuring high-quality standards are maintained while supporting business growth and regulatory compliance.
Key Responsibilities
- Lead the implementation, coordination, and continuous improvement of the quality risk management process across all functions
- Develop and maintain risk policies, procedures, and methodologies aligned with industry best practice
- Conduct regular, detailed risk assessments and establish mitigation strategies
- Create and manage an interactive site-wide risk register to highlight high-priority risks and required actions
- Facilitate cross-functional risk review meetings, presenting findings and supporting decision-making
- Monitor and report on risk management performance metrics
- Use recognised tools such as FMEA, FMECA, FTA, and statistical methods to identify and address risks
- Support regulatory inspections and customer audits, preparing subject matter experts and providing risk-related insights
- Deliver training on risk assessment and management to build capability across the business
About You
To succeed in this role, you will have:
- A degree in Biology, Chemistry, Pharmacy, or related discipline (or equivalent experience)
- Significant experience in a pharmaceutical or biotechnology quality environment within a manufacturing setting
- Strong knowledge of risk analysis methodologies, tools, and regulatory frameworks
- Proven experience developing and maintaining risk management strategies and systems
- Excellent analytical, organisational, and communication skills, with the ability to influence stakeholders at all levels
- Proficiency in Microsoft Office and experience using electronic quality management systems
- A clear understanding of GMP and regulatory expectations for Advanced Therapy Medicinal Products (ATMPs)
What’s on Offer
This is an opportunity to join an innovative and growing organisation at the forefront of advanced therapies. You will work closely with senior stakeholders, influence quality strategy, and help drive continuous improvement across the business.
Location: Edinburgh
Quality Risk Analyst employer: Kleboe Jardine Ltd
Contact Detail:
Kleboe Jardine Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Risk Analyst
✨Tip Number 1
Network like a pro! Reach out to professionals in the biotechnology sector on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Quality Risk Analyst role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICH Q9 guidelines and risk management methodologies. We recommend practising common interview questions related to quality risk management to show you’re the right fit for the team.
✨Tip Number 3
Showcase your analytical skills! Bring examples of past projects where you’ve successfully implemented risk management strategies. We want to see how you’ve made an impact in previous roles, so be ready to share those stories.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Quality Risk Analyst
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Risk Analyst role. Highlight your experience in quality risk management and any relevant methodologies you've used, like FMEA or FTA. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality risk management and how you can contribute to our team. Be sure to mention specific experiences that relate to the job description.
Showcase Your Analytical Skills: As a Quality Risk Analyst, strong analytical skills are key. In your application, provide examples of how you've successfully conducted risk assessments or developed risk management strategies in the past. We love seeing those real-world applications!
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our innovative team at StudySmarter!
How to prepare for a job interview at Kleboe Jardine Ltd
✨Know Your Risk Management Inside Out
Make sure you brush up on ICH Q9 guidelines and the specific risk analysis methodologies mentioned in the job description. Being able to discuss these in detail will show that you're not just familiar with the concepts, but that you can apply them effectively.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to demonstrate how you've handled risk assessments or developed risk management strategies in the past. Think of specific examples where you led a project or improved a process, and be ready to explain your thought process and outcomes.
✨Showcase Your Communication Skills
As a Quality Risk Analyst, you'll need to influence stakeholders at all levels. Practice articulating complex ideas clearly and concisely. You might even want to prepare a brief presentation on a relevant topic to demonstrate your ability to communicate effectively during the interview.
✨Familiarise Yourself with the Company’s Culture
Research the organisation's values and recent developments in the biotechnology sector. Understanding their mission and how they approach quality risk management will help you tailor your responses and show that you're genuinely interested in contributing to their goals.