QC Operations Associate Director

Berkley Group; Dundalk; Sur place; EUR 120 000 - 160 000; Plein temps

Résumé du poste

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)

Responsabilités

• 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

Connaissances

QC/GMP experience

LIMS/Empower/Trackwise

People leadership

CMO experience

Formation

Science degree

Outils

LIMS

Empower

MasterControl

TrackWise

Maximo

ECM

ELN

Description du poste

QC Operations Lead (Associate Director) – Dundalk, Co. Louth

A global biologics contract development and manufacturing organization is hiring a QC Operations Associate Director to join its Quality Control leadership team, reporting to the Head of QC.

You will build and lead a Biologics QC Operations team of 15-20 people for a new drug substance facility.

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

Qualifications

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

Required Skills

• 15+ years in QC/GMP, with strong QC Operations exposure
• Experience with LIMS, Empower, Master Control, Trackwise and Maximo
• People leadership; greenfield QC start-up experience ideal
• CMO experience is a plus