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