Senior QC Leader - GMP Compliance & Lab Ops

Aphex Group; 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

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