QC Operations Director – Biologics & Compliance Leader

WuXi Biologics; Leinster; On-site; EUR 150,000 - 190,000; Full time

Job summary

WuXi Biologics Ireland seeks a senior QC Operations Lead to shape local QC strategy and manage instruments, systems, sample management and regulatory compliance. You will build a world-class QC team, mentor ~15–20 staff, and partner with global sites to ensure GMP alignment and business objectives.

You will report to the Head of Quality Control and participate in start-up and routine operations while driving continuous improvements in a fast-paced biologics environment.

Qualifications

• 15+ years in Quality Control/GMP with leadership in QC operations.
• Experience establishing a QC function and building a team.
• Familiar with FDA/EMA regulations and ICH/GMP for biologics/pharma.

Responsibilities

• Lead QC leadership team and contribute to strategy, planning and execution.
• Oversee QC instruments, equipment, and computer systems validation.
• Supervise QC Project Lead Team and ensure on-time, high-quality support.
• Represent QC during regulatory inspections and audits.
• Drive continuous process improvements and operational excellence.

Skills

QC Leadership

GMP Compliance

Regulatory Audits

Team Leadership

Education

PhD in Chemistry/QA

MSc in related field

Tools

LIMS

Empower

ECM

Master Control

Trackwise

Maximo

Job description

WuXi Biologics Ireland seeks a senior QC Operations Lead to shape local QC strategy and manage instruments, systems, sample management and regulatory compliance. You will build a world-class QC team, mentor ~15–20 staff, and partner with global sites to ensure GMP alignment and business objectives.

You will report to the Head of Quality Control and participate in start-up and routine operations while driving continuous improvements in a fast-paced biologics environment.