Senior Specialist, QC Projects

Bristol-Myers Squibb; Cruiserath; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym access

Life assurance

Job summary

Bristol Myers Squibb in Ireland's Cruiserath facility is seeking a QC Projects Senior Specialist to support the QC Projects team within Multi-Product Cell Culture Drug Substance and Sterile Drug Product manufacturing. You will work under the QC Shared Services Projects Senior Manager and contribute to project scoping, tracking, training, and tech transfers.

The role emphasizes collaboration, regulatory awareness, and process improvements to enhance efficiency and compliance across QC operations.

Qualifications

• Minimum 2 years in a pharmaceutical/healthcare lab or related technical function.
• Demonstrate excellent written and verbal communication and ability to influence decisions.
• Strong knowledge of laboratory operation, especially training and testing requirements from receipt to CoA.
• Experience leading cross-functional teams and familiarity with regulatory requirements is desirable.

Responsibilities

• Support continuous improvement projects within the QC Projects team portfolio.
• Assist process improvements for onboarding, training plans and method-specific training.
• Support investigations, right-first-time improvements in QC.
• Manage projects assigned to self, including planning, tracking and escalation.
• Implement procedures and systems to maximise operating efficiency with Operational Excellence tools.
• Support regulatory inspections as required and ensure SOPs and training documents are approved.

Skills

Communication skills

Cross-functional teamwork

Project management

Regulatory knowledge

Process improvement

Education

BSc or higher in Science or related field

Job description

Position Summary

Cruiserath Biologics are seeking to recruit a QC Projects Senior Specialist to support the QC Projects team at its Multi-Product Cell Culture Drug Substance and Sterile Drug Product Manufacturing Facility . Reporting to the QC Shared Services Projects Senior Manager, they will support the activities in the Projects team as defined below.

Key Responsibilities

• Support the QC teams with continuous improvement projects as part of the QC Projects team portfolio.
• Support process improvements for onboarding, training plans and method specific training.
• Support process improvements for investigation reduction and right first time in the QC teams.
• Support Lean labs and automated scheduling tool process improvements.
• Project management of projects assigned to self, including planning, tracking, communication and escalations where needed.
• Strategically plan and implement procedures and systems to maximise operating efficiency through the use of Operational Excellence tools.
• Support of operational training activities to support efficiency and compliance across QC e.g support onboarding, delivering training and other training related requests.
• Support of tech transfers managed by the QC Projects team, where needed.
• Perform activities to support Drug Substance release e.g. tracking, data collation, where needed.
• Compliance with Standard Operating Procedures and Registered Specifications.
• Ensure any laboratory process improvements align with the BMS Safety culture.
• Approval of SOPs, Training documents etc., where required.
• Participate in regulatory agency inspections as required.

Qualifications & Experience

• Third level qualification (Degree) in Science or related discipline.
• Minimum of 2 years of experience in a pharmaceutical / healthcare laboratory or related technical function.
• Demonstrate excellent written and verbal communication skills and experience of working with teams and influencing decisions.
• A strong knowledge of laboratory operation, in particular training and testing requirements from receipt to CoA is required.
• Involvement in project scoping and tracking is desirable.
• Experience leading cross-functional teams and knowledge of applicable regulatory requirements is desirable.

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days of annual leave , access to BMS Cruiserath on-site gym and life assurance

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

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