Senior Quality Compliance Leader

Bristol Myers Squibb; Dublin; On-site; EUR 110,000 - 170,000; Full time

Job summary

Bristol Myers Squibb in Ireland is seeking a Senior Manager, ExM Quality Compliance to lead quality oversight across ExM, ensuring readiness for inspections and global regulatory compliance. You will guide the development of quality systems, manage risk assessments, and coordinate responses to Health Authority observations, while building strong cross-functional partnerships.

The role emphasizes continuous improvement and alignment with regulatory expectations to ensure patient safety and

Qualifications

• Experience supporting or leading regulatory inspections (FDA/EMA) and health authority interactions.
• Extensive knowledge of QMS, GMP, GDP and quality systems.
• Ability to identify gaps in QMS and drive corrective actions and continuous improvement.
• Strong cross-functional collaboration with QA, manufacturing, regulatory, and external CMOs.

Responsibilities

• Lead and develop direct reports where applicable; build a high-performance quality team.
• Own and optimize processes, forms, training materials, and metrics for ExM Quality.
• Ensure regulatory compliance of processes and alignment with Health Authority expectations.
• Review trends and metrics at Quality Councils, driving action and remediation.
• Coordinate annual risk assessments and quality remediation activities.

Skills

Regulatory inspections experience

Quality management systems

Risk assessment & CAPA

Cross-functional leadership

Pharma industry knowledge

Education

BSc or equivalent in Natural Sciences, Chemistry, Microbiology, Biology, or Pharmacy

Job description

Bristol Myers Squibb in Ireland is seeking a Senior Manager, ExM Quality Compliance to lead quality oversight across ExM, ensuring readiness for inspections and global regulatory compliance. You will guide the development of quality systems, manage risk assessments, and coordinate responses to Health Authority observations, while building strong cross-functional partnerships.

The role emphasizes continuous improvement and alignment with regulatory expectations to ensure patient safety and