QA Lab Ops Manager – Sterile Drug Product (Startup)

Bristol Myers Squibb; Fingal; 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

BMS Cruiserath Biologics in Ireland is seeking a Manager, QA Laboratory Operations for Sterile Drug Product. You will oversee QA start-up activities, contribute to GMP readiness, and manage method transfers and equipment qualification.

The role leads QC operations and ensures compliance across the commercial sterile drug product program. As a senior member, you will coach staff, partner with CQV/QC teams, drive continuous improvement, and support investigations and regulatory readiness.

Qualifications

• Bachelor/Masters in Science, or related discipline with a minimum of 5 years’ experience within the Biopharmaceutical/Pharmaceutical industry.
• Detailed knowledge of Sterile Drug Product would be a distinct advantage.
• Demonstrated knowledge of applicable EU, FDA and other regulatory requirements including Annex 1 and contamination control for sterile manufacture.
• Strong technical aptitude, global regulatory experience and ability to interface with regulators.
• Understanding of cGMP requirements for laboratory compliance including equipment, instrumentation and method qualification.
• Experience with deviation and change management processes.
• Ability to work independently and in a matrix team to meet accelerated timelines.
• Strong communication and analytical skills.
• Commitment to coaching and developing staff.

Responsibilities

• Provide QA oversight and support to start up activities, GMP operational readiness, Method Transfer and Equipment Qualification.
• Support QA approval of SOPs, deviations, CAPAs, change controls, risk assessments, equipment qualification docs and method transfer docs for QC operations.
• Coach and develop staff to achieve goals and complete tasks on time.
• Collaborate with CQV and QC teams on GMP scope for startup of sterile drug product operations at Cruiserath.
• Support Operational Excellence initiatives like 5S, Std Work, LSW, Kaizen.

Skills

QA oversight

GMP compliance

Sterile drug product

Staff coaching

Regulatory interfacing

Education

Bachelor’s or Master’s in Science

Job description

BMS Cruiserath Biologics in Ireland is seeking a Manager, QA Laboratory Operations for Sterile Drug Product. You will oversee QA start-up activities, contribute to GMP readiness, and manage method transfers and equipment qualification.

The role leads QC operations and ensures compliance across the commercial sterile drug product program. As a senior member, you will coach staff, partner with CQV/QC teams, drive continuous improvement, and support investigations and regulatory readiness.