QA Lab Ops Manager - Sterile Drug Product Start-Up

Bristol Myers Squibb UK & Ireland; Leinster; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family medical allowance

27 days annual leave

Life assurance

On-site gym

Job summary

Bristol Myers Squibb is seeking an experienced Manager, QA Laboratory Operations for Sterile Drug Product at the Cruiserath Biologics site in Ireland. You will lead QA activities during start-up, ensure GMP readiness, and guide QC start-up and method transfer efforts as the project scales to commercial operations.

The role requires strong leadership, regulatory knowledge, and a proven ability to coach teams in a fast-paced, multi-product environment.

Qualifications

• Bachelor/Masters in Science or related discipline with a minimum of 5 years’ experience in Biopharmaceutical/Pharmaceutical industry
• Knowledge of Sterile Drug Product is a plus
• Strong understanding of EU/FDA regulatory requirements incl. Annex 1 and contamination control for sterile manufacture

Responsibilities

• Provide QA oversight during start up activities, GMP readiness, method transfer and equipment qualification
• Coach and develop staff to meet operational goals and timely task completion
• Partner with CQV and QC teams to deliver GMP scope for startup of sterile drug production
• Support Operational Excellence initiatives (5S, Std Work, Lean) and self-inspection programs
• Support routine QA Laboratory Operations for testing and release of commercial sterile products

Skills

Leadership

Communication

Presentation skills

Troubleshooting

Problem solving

Time management

Organizational skills

Coaching and mentoring

Influencing others

Education

Bachelor/Masters in Science

Job description

Bristol Myers Squibb is seeking an experienced Manager, QA Laboratory Operations for Sterile Drug Product at the Cruiserath Biologics site in Ireland. You will lead QA activities during start-up, ensure GMP readiness, and guide QC start-up and method transfer efforts as the project scales to commercial operations.

The role requires strong leadership, regulatory knowledge, and a proven ability to coach teams in a fast-paced, multi-product environment.