QC Trending & Projects Specialist — GMP

Bristol Myers Squibb; Fingal; On-site; EUR 65,000 - 90,000; 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 in Dublin seeks a Senior Specialist, QC Projects & Trending to drive annual product quality reviews (APQRs) and trend reporting, oversee the Cruiserath QC trending programme, and ensure GMP-compliant data handling and documentation.

You will lead cross-functional teams, manage digital scheduling using Smart QC, support continuous improvement projects, and help maintain inspection readiness while aligning with global QA standards.

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 all APQRs and annual trend reports, ensuring timely delivery.
• Contribute to the Cruiserath Method Performance Monitoring Programme, incorporating reference standard monitoring and invalid rate tracking.
• Conduct trend assessments in collaboration with SMEs, ensuring outcomes are documented and actioned.
• Manage the addition of new products to the trending programme following successful transfer to Cruiserath QC teams.
• Approve SOPs, trend data, non-conformance reports, and related documentation in accordance with GMP requirements.
• Support and execute activities in line with QCSAS roadmap for QC Trending.
• Provide oversight and support for QC digital scheduling using Smart QC and digital tools.
• Support the QC teams with continuous improvement projects as part of the QC Projects team portfolio.
• 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.
• Maintain current knowledge of corporate and industry requirements, regulatory guidance, and compliance trends as they relate to QC Trending and aseptic manufacturing.
• Participate in regulatory agency inspections and support inspection readiness activities as required

Skills

Communication

Teamwork

GMP knowledge

Education

B.Sc. in Biochemistry or Pharmaceutical Science

Tools

Smart QC

Job description

Bristol Myers Squibb in Dublin seeks a Senior Specialist, QC Projects & Trending to drive annual product quality reviews (APQRs) and trend reporting, oversee the Cruiserath QC trending programme, and ensure GMP-compliant data handling and documentation.

You will lead cross-functional teams, manage digital scheduling using Smart QC, support continuous improvement projects, and help maintain inspection readiness while aligning with global QA standards.