Senior QC Trends & Projects Specialist

Bristol-Myers Squibb Co; Cruiserath; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym

Life assurance

Job summary

Bristol Myers Squibb is seeking a Senior Specialist for QC Projects & Data Privacy at the Cruiserath site in Ireland. You will lead trending activities, approve documentation, and drive continuous improvement across QC functions, collaborating with SMEs and global teams to ensure GMP compliance.

You will work within four work models and contribute to data privacy initiatives while supporting regulatory readiness and inspection activities.

Qualifications

• Minimum B.Sc. in Biochemistry, Pharmaceutical Science, or a closely related discipline.
• At least 2 years' experience in a GMP laboratory environment, ideally within a biologics setting.
• 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.
• Proven ability to work flexibly within a team environment and adapt to changing business needs

Responsibilities

• Define, schedule, coordinate, and drive activities required for completion of APQRs and annual trend reports.
• Contribute to Cruiserath Method Performance Monitoring Programme with reference standard monitoring.
• Conduct trend assessments with SMEs and document outcomes for action.
• Manage adding new products to the trending programme after transfer to Cruiserath QC teams.
• Approve SOPs, trend data, non-conformance reports, and related GMP documentation.
• Support QC digital scheduling using Smart QC and ensure compliance across QC functions.
• Lead continuous improvement projects and Lean lab initiatives.
• Plan and implement procedures and systems to maximise operating efficiency.

Skills

GMP experience

Analytical trending

Cross-functional

Project management

Regulatory compliance

Communication skills

Education

B.Sc. in Biochemistry or Pharmaceutical Science

Tools

Smart QC

Job description

Bristol Myers Squibb is seeking a Senior Specialist for QC Projects & Data Privacy at the Cruiserath site in Ireland. You will lead trending activities, approve documentation, and drive continuous improvement across QC functions, collaborating with SMEs and global teams to ensure GMP compliance.

You will work within four work models and contribute to data privacy initiatives while supporting regulatory readiness and inspection activities.