Senior Specialist, QC Projects & Trending

Bristol Myers Squibb; Cruiserath; 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 at BMS Cruiserath

Life assurance

Job summary

Bristol Myers Squibb in Cruiserath, Ireland seeks a QC Trending Analyst to drive APQRs and trend reporting within a GMP environment. You will contribute to performance monitoring, assess trends with SMEs, and manage product additions to the trending programme as part of the Cruiserath QC teams. The role requires a B.Sc.

in Biochemistry or related field, 2+ years GMP lab experience, strong communication, and teamwork skills. Knowledge of Smart QC and project management is desirable.

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 Annual Product Quality Reviews (APQRs) and annual trend reports.
• Contribute to the Cruiserath Method Performance Monitoring Programme, incorporating reference standard monitoring and invalid rate tracking.
• Conduct trend assessments in collaboration with relevant SMEs, ensuring outcomes are clearly documented and actioned.
• Manage the addition of new products to the trending programme following successful transfer to the 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 and digital scheduling using Smart QC.
• Support Lean labs and automated scheduling tool process improvements and project management within the QC Projects portfolio.

Skills

Communication skills

GMP experience

Teamwork

Lab operations knowledge

Data analysis

Education

B.Sc. in Biochemistry or related

Tools

Smart QC (SQC)

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.

Key Responsibilities

Analytical Trending & Method Performance

• Define, schedule, coordinate, and drive activities required for completion of all Annual Product Quality Reviews (APQRs) and annual trend reports, ensuring timely delivery in line with due dates
• Contribute to the Cruiserath Method Performance Monitoring Programme, incorporating reference standard monitoring and invalid rate tracking
• Conduct trend assessments in collaboration with relevant Subject Matter Experts (SMEs), ensuring outcomes are clearly documented and actioned
• Manage the addition of new products to the trending programme following successful transfer to the Cruiserath QC teams
• Approve SOPs, trend data, non-conformance reports, and related documentation in accordance with GMP requirements

Digital Scheduling & Continuous Improvement Projects

• Support and execute activities in line with QCSAS roadmap for QC Trending, ensuring alignment with site and global procedures.
• Provide oversight and support for QC digital scheduling using Smart QC and digital tools, ensuring solutions remain compliant, fit for purpose, and aligned across QC functions.
• 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.

Stakeholder Engagement & Compliance

• 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

Qualifications & Experience

Essential

• 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

Desirable

• Experience with Smart QC (SQC) platform and/or QC project management
• Involvement in project scoping and tracking.
• Experience leading cross-functional teams and knowledge of applicable regulatory requirements is desirable.

Key Competencies

• Technical Expertise - In-depth understanding of GMP analytical trending and QC systems
• Communication - Clear, confident communicator with strong stakeholder management skills
• Compliance Focus - Thorough understanding of regulatory expectations and inspection readiness
• Collaboration - Proven ability to contribute to and lead within a team-based, collaborative environment

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

We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.

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

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable acc