Overview
CLS is currently going through an unprecedented and exciting period of growth and development and is looking for dynamic, dedicated and solutions driven team members, who want to be part of the company’s continued success.
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 aflexible and managedquality 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.
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 provides 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.
This position is located in RosMuc, Connemara, Co.Galway. Please consider the possible commute before applying.
What’s Important
* Working experience of ISO 17025, 9001 and INAB requirements.
* Demonstrated experience in a Quality leadership role.
* Understanding thealignment of quality goals with strategic objectives.
* Collaborate 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 and drive continuous improvement.
The Role
Quality Management System (QMS):
* Implement, and maintain the QMS in accordance with ISO 17025, 9001, INAB and any other applicable regulatory standards.
* Lead internal and external audits, including client and accreditation body audits.
* Management of the Internal Audit Schedule, conducting monthly auditor meetings and assigning Internal Audits to the Internal Audit team.
* Oversee document control, change management, and CAPA processes.
* Monitor and analyse quality metrics, trends, and non-conformance reports to drive continuous improvement.
* Report on the performance of the quality management system to the management review.
* Lead and perform risk assessments related to quality, compliance and performance.
* Define and monitor quality KPIs and report on trends and lead action plans.
* 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.
* Coordination of internal verification and external calibration schedule.
* Support the training and competency assessment of laboratory employees on quality-related procedures.
* Coordinate the externallaboratory proficiencies, trending of results and implementation of corrective actions and liaise with the 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.
* Stay up-to-date and ensure current compliance with relevant regulatory and industry standards (e.g., ISO,INAB, FDA, EPA etc)
* Support the validation and implementation of new technologies to enhance the client fulfilment.
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.
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 is 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 organizational skills.
* Ability to manage competing priorities and meet deadlines
* Analytical mindset with the capability to make informed decisions and solve problems.
* Clear and effective communication capabilities.
* Commitment to maintaining confidentiality and professional integrity.
* Ability to work collaboratively across teams and build strong working relationships.
This is an excellent opportunity to step into a well-established system and play a central role in shaping the next phase of our laboratory’s quality management. #J-18808-Ljbffr