QC Manager

Recruitment by Aphex; Galway; On-site; EUR 90,000 - 120,000; Full time

Job summary

Aphex Group is seeking a technically strong leader for its Quality Control laboratory in Ireland. The role ensures all analytical testing on raw materials and finished products complies with GMP, GLP, and regulatory requirements (EU & US) while supporting the Head of Quality in maintaining readiness for inspections.

The ideal candidate will manage laboratory operations, oversee method transfer, development and validation activities, and lead a team of QC personnel with a focus on data integrity

Qualifications

• Bachelor’s degree in a science-based discipline required.
• Minimum 5 years in a pharmaceutical environment with leadership in a cGLP setting.
• Experience with EU GMP and US FDA guidelines.
• Strong organisational, time management and prioritisation skills.
• Excellent communication and interpersonal skills; ability to lead a team.
• Proficient in MS Office; practical, action-orientated and methodical.

Responsibilities

• Provide technical leadership for the Quality Control laboratory to ensure analytical testing complies with GMP, GLP, and regulatory requirements (EU & US).
• Oversee testing and release of raw materials and finished products with a focus on data integrity and inspection readiness.
• Manage QC stability program, calibration/maintenance, and scheduling of analyses across sites; review and approve results and reports.

Skills

Leadership

Data integrity

Organisational skills

Communication

Analytical thinking

Problem-solving

MS Office

Team leadership

Education

Bachelor's degree in a science-based discipline

Tools

MS Office

Job description

Purpose

To provide technical expertise and leadership for the Quality Control laboratory, ensuring all analytical testing on raw materials and finished products complies with GMP, Health & Safety, and regulatory requirements (EU & US). The role supports the Head of Quality in maintaining a state of control and readiness for inspections.

Responsibilities

Testing & Compliance: Ensure all laboratory testing is conducted in accordance with current EU and US regulatory requirements, with a paramount focus on data integrity. Oversee timely testing and release of raw materials and finished products.

Laboratory Operations: Manage the QC stability program, equipment maintenance/calibration, and scheduling of analysis across sites. Ensure timely review and approval of results, protocols, and reports.

Technical Leadership: Provide guidance and perform detailed root cause investigations for OOS results, equipment failures, and analytical errors. Oversee method transfer, development, and validation activities.

Quality Systems: Ensure adherence to SOPs and GLP standards. Assist in hosting regulatory inspections and customer audits, and implement corrective actions in a timely manner. Review and approve GMP documentation and SOPs.

Team & Resource Management: Lead, train, and develop laboratory personnel. Conduct performance reviews, identify continuous improvement initiatives, and manage laboratory capacity and budget. Provide monthly KPI reporting.

Requirements

Bachelor's degree in a science-based discipline.

Minimum 5 years in a pharmaceutical environment, with experience in Leadership in a cGLP setting and knowledge of EU GMP and US FDA guidelines.

Strong organisational, time management, and prioritisation skills. Excellent communication and interpersonal skills with the ability to lead a team. Strong analytical and problem-solving ability. Proficient in MS Office.

Practical, action-orientated, and methodical. Maintains high ethical standards and escalates issues appropriately. Flexible and proactive.