QA Lab Ops Manager — Sterile Drug Product

Bristol Myers Squibb; Cruiserath; On-site; EUR 90,000 - 130,000; Full time

Job summary

Bristol Myers Squibb in Cruiserath, Ireland, seeks a Manager, QA Laboratory Operations for Sterile Drug Product. You will support startup QA oversight, GMP readiness, method transfers, and equipment qualification, then sustain routine testing and release for commercial sterile products.

The role demands coaching staff, regulatory acumen, and collaboration with CQV/QC teams. The start-up project spans aseptic filling, vial and syringe operations, and new clean utilities, offering diverse

Qualifications

• Bachelor or Master in Science or related discipline.
• Knowledge of EU/FDA regulatory requirements and Annex 1.
• Experience with cGMP in laboratory settings.

Responsibilities

• Provide QA oversight during start-up, GMP readiness, method transfer, and equipment qualification.
• Approve SOPs, deviations, CAPAs, change controls, risk assessments, and method transfer docs.
• Coach and develop staff to meet operational goals and schedules.
• Collaborate with CQV and QC teams on startup GMP scope.
• Drive operational excellence and continuous improvement initiatives.

Skills

QA oversight

GMP compliance

Method Transfer

Equipment Qualification

SOP approvals

Deviations handling

CAPA management

Change controls

Risk assessments

Staff coaching

Education

Bachelor/Master in Science or related discipline

Job description

Bristol Myers Squibb in Cruiserath, Ireland, seeks a Manager, QA Laboratory Operations for Sterile Drug Product. You will support startup QA oversight, GMP readiness, method transfers, and equipment qualification, then sustain routine testing and release for commercial sterile products.

The role demands coaching staff, regulatory acumen, and collaboration with CQV/QC teams. The start-up project spans aseptic filling, vial and syringe operations, and new clean utilities, offering diverse