Quality Manager

3 days ago


Galway, Galway, Ireland Complete Laboratory Solutions Full time
Overview

Founded in 1994, Complete Laboratory Solutions (CLS) is the highest accredited contract laboratory in Ireland and the leading provider of sampling, analysis, and analysts to the pharmaceutical, medical device, food, and environmental industries.

As well as analysis and testing at our commercial laboratories, CLS builds strategic partnerships with its clients to deliver a flexible and managed quality solution (FlexiQ) by supplying organisations with highly skilled, work-ready quality professionals on a temporary, project-specific, or long-term basis. This service can be provided at a CLS site or directly at the client's location.

This position arises as part of succession planning to ensure a smooth transition within our Quality function. The successful candidate will receive structured support and handover to become fully familiar with the role and the organisation before taking on full responsibility.

Location: RosMuc, Co. Galway

Job Title, Summary & Reporting Line

Reporting to the Chief Executive Officer (CEO), the Quality Manager will lead and maintain the Quality Management System (QMS) for our laboratories, which provide microbiology and chemistry testing services to the food and environmental industries. The Quality Manager will be responsible for ensuring that all testing activities comply with applicable regulatory requirements (ISO 17025, ISO 9001), client specifications, and internal quality standards. The role will also involve active participation in the site leadership team, contributing to decision-making, guiding strategy, and supporting the implementation of business plans.

What's Important
  • Working experience of ISO 17025, 9001 and INAB requirements.
  • Demonstrated experience in a Quality leadership role.
  • Understanding the alignment of quality goals with strategic objectives.
  • Collaborating cross-functionally with business, operations, and leadership teams to embed quality into all aspects of the business and drive measurable improvements in customer satisfaction, compliance, and operational efficiency.
  • Commitment to driving continuous improvement.
Key Responsibilities
  • Quality Management System (QMS): Implement and maintain the QMS in accordance with ISO 17025, 9001, INAB and other applicable regulatory standards.
  • Audits: Lead internal and external audits, including client and accreditation body audits.
  • Internal Audit Schedule: Manage the Internal Audit Schedule, conduct monthly auditor meetings, and assign Internal Audits.
  • Documentation & CAPA: Oversee document control, change management, and CAPA processes.
  • Quality Metrics: Monitor and analyse quality metrics, trends, and non-conformance reports to drive continuous improvement.
  • Management Review: Report on QMS performance at management review.
  • Risk & KPIs: Lead and perform risk assessments related to quality, compliance, and performance.
  • Quality KPIs: Define, monitor, and report on Quality KPIs including:
    • Turnaround Times (TAT)
    • Client communication and responsiveness
    • Client service fulfilment
    • Client surveys and execution of action plans to deliver continuous improvements
  • Executive Reporting: Prepare executive-level quality performance reports.
Laboratory Oversight
  • Collaborate with laboratory managers to review and approve SOPs, validation protocols, and method development documentation.
  • Ensure the validity, reliability, and accuracy of microbiology and chemistry testing procedures.
  • Coordinate internal verification and external calibration schedules.
  • Support training and competency assessment of laboratory employees on quality-related procedures.
  • Coordinate external laboratory proficiencies, trend results, implement corrective actions, and liaise with Laboratory Supervisors.
  • Ensure laboratory compliance with environmental and food testing requirements.
Customer And Stakeholder Interaction
  • Act as the primary quality contact for clients and regulatory bodies.
  • Manage quality-related client inquiries, complaints, and audit follow-ups.
Continuous Improvement
  • Lead root cause analysis and process improvement initiatives.
  • Implement quality improvement strategies in collaboration with cross-functional teams.
  • Drive efficiencies in turnaround time (TAT), service delivery, team performance, and client fulfilment.
  • Develop and introduce new technology review processes, and support the validation and implementation of these technologies.
  • Stay up-to-date and ensure compliance with relevant regulatory and industry standards (ISO, INAB, FDA, EPA, etc.).
Leadership And Management
  • Motivate team to achieve targets and optimise the use of resources at all times.
  • Engage in the performance appraisal process with team members, identifying areas for development and progression.
  • Have an active involvement in the on-site leadership team, contributing to people and technical development, and ensuring the best commercial outcomes are achieved while maintaining continuous compliance.
  • Support the business in adapting to change and communicate effectively across the site.
  • Contribute actively to site leadership, playing a role in guiding decisions and implementing strategic initiatives.
Where You've Come From
  • Bachelor's degree in Microbiology, Chemistry, Biology, or related scientific discipline (Master's preferred).
  • Minimum of 5 years of experience in a laboratory quality assurance role, including at least 2 years in a leadership capacity.
Who You Are
  • Strong knowledge of ISO 17025, 9001, INAB and relevant regulatory guidelines (FDA, EPA, etc.).
  • Experience in food or environmental testing laboratories strongly preferred.
  • Demonstrated ability to manage audits, maintain QMS, and lead quality investigations.
  • Proficiency in quality management software and Microsoft Office Suite.
  • Exceptional attention to detail and organisational skills.
  • Ability to manage competing priorities and meet deadlines.
  • Analytical mindset with strong decision-making and problem-solving capability.
  • Clear and effective communicator with strong interpersonal skills.
  • Professional integrity and discretion.
  • Ability to work collaboratively across teams and build strong relationships.

This is an excellent opportunity to step into a well-established system, play a central role in shaping the next phase of our laboratory's quality management, and be part of the business leadership team guiding CLS through its next stage of growth.

Details
  • Seniority level: Mid-Senior level
  • Employment type: Full-time
  • Job function: Quality Assurance
  • Industries: Research Services
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