Purpose of the Role
The Lead, Calibration & Analytical Lab is responsible for leading and overseeing analytical laboratory setup and calibration activities, ensuring full compliance with GMP, regulatory requirements, and internal quality standards. This role manages the analytical and calibration functions and associated personnel to achieve departmental and site objectives, while providing strong technical leadership, operational oversight, and continuous improvement across services that support ADC and its customers.
Responsibilities
Lead and oversee analytical laboratory setup activities, ensuring adherence to GMP, regulatory, and internal quality standards.
Manage the Analytical and Calibration departments, including personnel, systems, and daily operations, in alignment with site and departmental goals.
Act as the site Subject Matter Expert (SME) for analytical laboratories, calibration systems, and Maximo, supporting internal and external audits.
Manage the site Maintenance and Calibration Management System (Maximo) and associated assets, including authorisation of system changes.
Provide technical leadership for analytical test method transfers and the setup of new analytical laboratory spaces.
Ensure compliant control of production, inspection, measuring, and test equipment across the site.
Liaise cross‑functionally and divisionally as technical lead for site projects, ensuring alignment with timelines and strategic objectives.
Procure laboratory equipment and consumables based on forecasted requirements, site needs, and budget constraints.
Negotiate, manage, and maintain contracts and relationships with external calibration and analytical service providers.
Ensure quality and compliance issues are promptly identified, investigated, and addressed through effective corrective and preventive actions.
Lead and manage departmental activities during audits and represent the site as SME where required.
Oversee periodic review of procedures to ensure ongoing compliance and alignment with business needs.
Manage departmental budgets, approve purchases and invoices, and control expenditure within defined limits.
Support onboarding, training, performance management, and career development of team members, fostering a strong culture of quality and continuous improvement.
Promote and manage Health & Safety within the department, proactively reducing risk and reinforcing shared accountability.
Ensure accurate, timely, and reliable data reporting to Site, Division, and Corporate management to support quality and business decisions.
Education And Experience
NFQ Level 7 qualification or higher in Engineering, Science, or a related discipline.
Minimum of 4 years’ experience managing calibration system requirements within the medical device and/or pharmaceutical industry.
Proven experience operating in a regulated GMP environment, including audit participation and quality system management.
Demonstrated ability to lead teams, manage complex technical operations, and drive continuous improvement initiatives.
What We Offer
Attractive compensation package that includes competitive pay.
Family health insurance.
Excellent pension scheme.
Life assurance.
Career Development.
Fantastic new facility.
Growing business plus access to many more benefits.
Abbott is an equal opportunities employer.
#J-18808-Ljbffr