Quality Assurance Supervisor

Job Summary

We have an exciting opportunity to join Charles River Labs based in Rathcoole Co. Dublin D24 NF21.

The Quality Assurance (QA) Supervisor is responsible for leading a team of QA specialists to ensure products processes and services meet established quality standards and regulatory requirements. This role oversees day-to-day QA operations supports continuous improvement initiatives and collaborates cross-functionally to drive operational excellence and compliance. The QA Supervisor provides coaching guidance and performance management for the QA team while ensuring timely and accurate execution of quality activities.

Essential duties and responsibilities:

• Manage activities of assigned group(s) to ensure optimum performance of the team and meet business needs and timelines.
• Support personnel management activities such as hiring promotions training and development providing regular direction and feedback on performance disciplinary actions. Preparing and delivery annual performance and salary reviews.
• Supervise mentor and develop a team of QA specialists.
• Promote a culture of quality accountability continuous improvement and operational excellence.
• Oversee inspection testing auditing and documentation activities related to product or service quality.
• Ensure adherence to internal SOPs industry standards and applicable regulatory requirements (e.g. ISO GMP GDPR).
• Review and approve QA documentation including quality reports deviations CAPAs and inspection records.
• Monitor and analyse quality metrics to identify trends risks and opportunities for improvement.

Essential duties and responsibilities continued:

• Develop maintain and enhance efficient work procedures and processes aligned with company standards and quality directives.
• Lead the preparation and maintenance of study and QA files for client audits sponsor site visits and regulatory inspections; ensure QA audit files are properly retained.
• Act as lead host for client site visits and regulatory inspections managing communications inquiries and all audit-related activities.
• Develop corrective and preventive actions (CAPAs) in response to client and regulatory findings and coordinate drafting of follow-up correspondence with affected departments and report outcomes to senior management.
• Review and approve SOPs protocols batch records reports and other regulated records (e.g. deviations change controls CAPAs) involving technically complex processes to ensure accuracy and compliance.
• Lead the execution and scheduling of internal facility inspections to evaluate the effectiveness of site quality systems.
• Support the review negotiation and maintenance of Customer and Supplier Quality Agreements.
• Provide QA support for validation activities including computer systems controlled environments test methods and manufacturing equipment.
• Facilitate host and present at Quality Management Review (QMR) meetings.
• Participate in and/or lead QA-related projects and cross-functional continuous improvement initiatives.
• Ensure timely resolution of non-conformances and effective implementation of corrective and preventive actions.
• Maintain accurate and compliant quality records and ensure the team adheres to controlled document processes.
• Ensure site compliance with applicable regulations and corporate policies; escalate identified quality or compliance risks to management.
• Collaborate closely with Operations Laboratories Customer Service Facilities Product Compliance and other functions to ensure quality standards are embedded across workflows.
• Lead or support continuous improvement activities to enhance quality operations efficiency employee engagement and service to internal and external customers.
• Communicate quality issues insights and recommendations effectively to stakeholders.

Education and Experience:

• Bachelors degree (B.S. /B.A.) or equivalent preferably in a life science.
• Extensive experience in a Quality Assurance role minimum 5 years.
• Proven supervisory experience essential.
• Qualified Person (QP) qualification is highly desirable.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Experience with assisting or managing QA audits and inspections as well as interfacing with regulatory agencies.
• Detailed knowledge of GMP and ISO standards.
• Strong technical QMS experience essential.

Competencies:

• Excellent communication and influencing skills (Fluent in English written and verbal).
• Ability to collaborate and develop strong working relationships with key stakeholders.
• Effective problem solving and decision-making skills.
• Strong leadership skills.
• Ability to motivate and lead a team.
• Business Acumen. Excellent attention to detail.
• Strong organisational skills with the ability to self-manage and prioritise as required.
• Experience with Microsoft Office applications and spreadsheet/database programs such as Access and Excel.