Manager, QA Laboratory Operations

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

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

BMS Cruiserath Biologics is seeking to recruit a Manager, QA Laboratory Operations for Sterile Drug Product.

Reporting to the Senior Manager, QA Laboratory Operations, the Manager will support the start-up of a commercial drug product manufacturing facility for its biologic's commercial portfolio and clinical pipeline and be the primary delegate for the Senior Manager. During start-up, this role will work in conjunction with the project team to provide QA oversight and support to QC start up activities, GMP operational readiness, Method Transfer and Laboratory Equipment Qualification activities.

Post start-up the successful candidate will be part of the QA Laboratory Operations team supporting routine commercial sterile drug product testing and release activities.

The start-up nature of this project will require adaptability & innovation due to the multiple project phases and multiple products onsite. The role will be both challenging & rewarding and will thus ensure that the successful candidate can seize a wide range of development opportunities within BMS. The Sterile Drug Product project scope includes construction and commissioning of new SDP product suite with parts prep, formulation, aseptic filling and capping of liquid & freeze-dried vials, aseptic filling of syringes, and Visual Inspection capabilities. The project also includes new and expanded clean utilities.

Key Responsibilities During Start Up

• Provide QA oversight and support to start up activities, GMP operational readiness, Method Transfer and Equipment Qualification
• Support qualification activities including QA approval of SOPs, deviations, CAPAs, change controls, risk assessments, equipment qualification documentation and method transfer documentation for QC operations.
• Responsible for coaching and development of staff and direct personnel to achieve operational goals and ensure the timely completion of tasks.
• Partnership with CQV and QC team in delivering the GMP scope of work associated with the startup of sterile drug product operations at Cruiserath.
• Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Key Responsibilities During Commercial Operations

• QA Laboratory Operations oversight of product testing and release activities for commercial and clinical sterile drug product
• Laboratory Investigation system owner for the QC laboratories and Contract Test laboratories Manage the QC Triage business process
• Laboratory Investigations SME during regulatory agency inspections
• QA Laboratory Operations Lead at Investigations Review Board (IRB)
• Liaising with manufacturing site and/or contract laboratory for complex investigations
• QA Approver for complex/multi-functional deviations, root cause investigations, QC Laboratory investigations, impact assessments and associated CAPAs
• QA Support Operational SOPs, test methods, forms and directives
• Annual Product Reviews (APQRs)
• Annual Trend reports
• Laboratory equipment/instrument qualification protocols and reports
• Method validations / technical transfers protocols and reports
• Responsible for coaching and development of staff and direct personnel to achieve operational goals and ensure the timely completion of tasks.
• Drive and support culture of continuous improvement initiatives and safe working practices.
• Support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.
• Support the execution of the Self Inspection programme
• Designee for Senior Manager, QA Laboratory Operations, when required
• Supporting the hiring, development and coaching of key members of the QA Laboratory Operations team

Qualifications & Experience

• The successful candidate must possess:
• 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 the principles of Annex 1 and how they translate into a contamination control strategy for sterile manufacture.
• A strong technical aptitude, global regulatory experience and demonstrated experience interfacing with regulators
• A thorough understanding of cGMP requirements for laboratory compliance including equipment, instrumentation and method qualification requirements
• Demonstrated in