Biologics QC Operations Director - Lead New Facility

Berkley Group; Dundalk; On-site; EUR 120,000 - 160,000; Full time

Job summary

Berkley Group is recruiting a QC Operations Lead (Associate Director) for Dundalk, Ireland. You will build and head a Biologics QC Operations team of 15–20 people for a new drug substance facility and report to the Head of QC.

You will own QC instruments and systems, drive LIMS/Empower/ECM/ELN implementations, and oversee qualification, calibration and audits, ensuring GMP compliance across the new facility.

Qualifications

• Science or quality degree (PhD or Master's desired)

Responsibilities

• Own QC instruments, equipment and systems, including qualification and CSV
• Lead implementation of LIMS, Empower, ECM and ELN
• Run QC sample management, calibration and PM programmes
• Supervise the QC Project Lead team as the link between QC, clients and stakeholders
• Represent QC in regulatory inspections and client audits
• Support QC design, construction and commissioning of the new facility

Skills

QC/GMP experience

LIMS/Empower/Trackwise

People leadership

CMO experience

Education

Science degree

Tools

LIMS

Empower

MasterControl

TrackWise

Maximo

ECM

ELN

Job description

Berkley Group is recruiting a QC Operations Lead (Associate Director) for Dundalk, Ireland. You will build and head a Biologics QC Operations team of 15–20 people for a new drug substance facility and report to the Head of QC.

You will own QC instruments and systems, drive LIMS/Empower/ECM/ELN implementations, and oversee qualification, calibration and audits, ensuring GMP compliance across the new facility.