Quality systems & digital quality manager

Quality Systems & Digital Quality Manager

Scotland | Competitive Salary + Benefits

We are currently partnering with a leading life science organisation to recruit an experienced Quality Systems & Digital Quality Manager into a senior leadership role. This is a fantastic opportunity to shape and evolve quality systems within a rapidly growing and highly regulated environment.

This position plays a pivotal role in driving Quality Management Systems (QMS), Validation strategy, and Digital Quality transformation, with clear visibility at senior leadership level and the opportunity to deputise for the Head of Quality.

The Role

You will be responsible for leading the strategic development and operational excellence of the site’s QMS, ensuring it remains robust, scalable and aligned to business growth. Alongside this, you will oversee validation activities and drive forward digital quality initiatives across the site.

Key Responsibilities

• Leading the ongoing development and optimisation of the site QMS, ensuring compliance and operational effectiveness
• Driving a proactive, risk-based approach to quality management
• Overseeing core quality systems including Deviations, CAPA, Change Control, Document Management and Training
• Establishing and analysing quality metrics and KPIs to drive continuous improvement
• Supporting and leading regulatory inspections and client audits
• Providing leadership across the validation lifecycle (process, cleaning, equipment and computerised systems)
• Driving digital transformation initiatives, including QMS platforms, automation and data analytics
• Leading implementation and governance of GxP-compliant systems
• Developing and mentoring a high-performing quality team

About You

We are looking for a confident and collaborative quality leader with a strong technical background and a passion for continuous improvement.

You Will Bring

• Degree in a relevant scientific or technical discipline
• Significant experience within pharmaceutical, biotech or medical device manufacturing (CDMO highly advantageous)
• Strong expertise in QMS management, validation, and regulatory compliance
• In-depth knowledge of GMP/GxP requirements and data integrity principles (ALCOA++)
• Experience working with computerised systems compliance frameworks (for example Annex 11, 21 CFR Part 11, and GAMP 5)
• Proven leadership and stakeholder management skills
• Exposure to digital quality systems, automation, or data-driven quality environments

Why Apply?

• Strategic, high-impact role with real influence on site quality direction
• Opportunity to lead digital transformation in a regulated environment
• Strong visibility with senior leadership and scope for progression
• Collaborative and forward-thinking organisation

Ready to make an impact? If you are looking for a role where you can combine quality leadership, validation expertise and digital innovation, we would love to hear from you.