Head of Operations / Site Lead - diagnostics

Bangor
23 hours ago
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Your new company
You'll be joining a global leader in healthcare technology, recognised for pioneering breakthroughs that improve patient outcomes and advance diagnostic innovation worldwide. With a strong commitment to sustainability, diversity and continuous learning, the organisation empowers its people to grow, challenge convention and drive meaningful impact. At this UK manufacturing centre, you'll be part of a collaborative leadership team dedicated to delivering high‑quality diagnostic products that support clinicians and patients across the globe.

Your new role
This is a permanent position, requiring a majority on-site presence (3+ days per week), that is part of the Executive Leadership Team for this high-performing site.
Main responsibilities will include, but aren't limited to:

Develop and execute the Technical Operations strategy for immunoassay platforms, ensuring alignment with business objectives and delivery of supply, quality and productivity targets.
Lead technical support for raw material and reagent manufacturing, including troubleshooting, process optimisation and strengthening supply resilience.
Oversee robust root‑cause investigations and corrective actions for technical issues, ensuring operational excellence.
Build, mentor and inspire a high‑performing Technical Operations team, fostering a culture of innovation, accountability and continuous improvement.
Ensure full compliance with regulatory standards (ISO 13485, FDA, MHRA) and support audits, inspections and regulatory submissions.
Drive technical projects including material changes, product improvements and new product introductions, managing timelines, budgets and stakeholder communication.
Collaborate closely with Manufacturing, Quality, R&D, Supply Chain and other functions, acting as a key technical liaison across the organisation.
Manage departmental budgets, resource allocation and operational performance while maintaining high standards of quality and delivery.
Champion a proactive Environmental, Health & Safety culture across all Technical Operations activities.

What you'll need to succeed

BSc or MSc (PhD preferred but not essential) in Biology, Chemistry, Biochemistry, Biomedical Sciences or a related discipline (or equivalent experience).
Significant experience in technical support within diagnostics or biologics manufacturing.
Strong leadership experience managing multidisciplinary teams in GMP environments.
Deep understanding of immunoassay platforms.
Proven track record in process optimisation, troubleshooting and technology transfer.
Strong knowledge of regulatory frameworks including FDA, EMA, ICH and ISO 13485.
Experience with Lean, Six Sigma or other continuous improvement methodologies.
Excellent communication, stakeholder management and organisational leadership skills.
Ability to manage complex projects with strategic thinking, critical analysis and a pragmatic approach.
Confidence working with data insights, predictive analytics and emerging AI/ML tools.

What you'll get in return
You'll get the chance to make a major impact on a leading global diagnostics company, taking on a role with significant managerial responsibility and the chance to further develop your career within a collaborative and high-performing environment.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.

Keywords: technical, operations, diagnostics, manufacturing, immunoassay, assay, platforms, process, engineering, troubleshooting, GMP, ISO13485, FDA, MHRA, quality, improvement, Lean, Six, Sigma, lifecycle, management, reagents, raw, materials, optimisation, leadership, biologics, compliance, analytics

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