Senior Specialist, QC Projects & Trending

Bristol Myers Squibb; Fingal; Presencial; EUR 65.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym

Life assurance

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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

Conocimientos

Communication

Teamwork

GMP knowledge

Educación

B.Sc. in Biochemistry or Pharmaceutical Science

Herramientas

Smart QC

Descripción del empleo

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 willbe part ofa 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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo‑accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud‑protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application‑related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607137 : Senior Specialist, QC Projects & Trending