Biologics QC Operations Lead — Strategy & Compliance

Life Science Recruitment; Leinster; On-site; EUR 120,000 - 180,000; Full time

Job summary

Life Science Recruitment is seeking a QC Operations Lead (Associate Director) to join the team on a permanent basis in Ireland. The role oversees QC instruments, systems, sample management, and regulatory compliance, partnering with senior leaders to develop the local QC strategy aligned with global QC functions.

The successful candidate will build a world-class Biologics QC Operations team, lead the QC strategy, and represent Operations in regulatory inspections and audits.

Qualifications

• University degree in related science/quality discipline required.
• Ph.D. with 5-8 years of experience or Masters with 7-10 years of experience in relevant fields.
• Over 15 years’ experience in Quality Control/GMP environment preferred.
• Experience with LIMS, Empower, ECM, Master Control, Trackwise, Maximo.
• Experience with MS Word, Excel, PowerPoint, Visio, and Project.
• Management/supervision of personnel with scheduling/priority setting.
• Regulatory inspections and internal/customer audits preferred.
• Experience working in a CMO is a plus.

Responsibilities

• Lead QC leadership strategy and business planning.
• Collaborate with senior leaders to meet targets and objectives.
• Support design, construction, and commissioning of new biologics QC facility.
• Build and coach a 15–20 headcount QC Operations team.
• Manage QC instruments, equipment, systems, and calibration/logbooks.
• Oversee QC computer systems (LIMS, Empower, ECM, ELN).
• Represent QC in regulatory inspections and client audits.
• Drive continuous improvement and operational excellence.

Skills

Leadership

Project management

Quality awareness

Regulatory knowledge

Education

PhD in Chemistry/Analytical Chemistry/Biology/Engineering/IT

MS in related field

University degree in related science/quality discipline

Tools

LIMS

Empower

ECM

Master Control

Trackwise

Maximo

Microsoft Word

Excel

Job description

Life Science Recruitment is seeking a QC Operations Lead (Associate Director) to join the team on a permanent basis in Ireland. The role oversees QC instruments, systems, sample management, and regulatory compliance, partnering with senior leaders to develop the local QC strategy aligned with global QC functions.

The successful candidate will build a world-class Biologics QC Operations team, lead the QC strategy, and represent Operations in regulatory inspections and audits.