Senior Quality Compliance Lead, Global External Manufacturing

Bristol-Myers Squibb Co; Dublin; On-site; EUR 90,000 - 135,000; Full time

Job summary

Bristol Myers Squibb Co in Dublin is seeking a Senior Manager, Quality Compliance to oversee GMP quality compliance for pharma intermediates, API, drug products and biologics CMOs within External Manufacturing.

The role leads continuous improvement initiatives, acts as Local Process Owner for key Quality Systems, guides major investigations, supports recalls and HA observations, and collaborates with Quality Operations and cross-functional teams to maintain regulatory alignment.

Responsibilities

• Lead Continuous Improvement and/or Compliance projects for External Manufacturing network.
• Serve as Local Process Owner for Quality Systems (e.g., Change Control, Deviations, CAPA, Complaints).
• Lead the FIT/FIRM processes for major investigations involving ExM manufacture.
• Prepare and present information to senior management in support of FIT/FIRM processes.
• Support the Product Action Committee (PAC) process for recalls associated with CMOs managed by ExM.
• Provide quality/compliance support to Quality Operations Managers.
• Raise Notifications to Management (NTMs) for major and critical investigations.
• Review and approve responses to Health Authority (HA) observations prepared by CMOs to ensure regulatory alignment.
• Write and/or review SOPs and other controlled documents to ensure compliance with BMS standards and cGMP requirements.
• Represent ExM on global quality teams, initiatives, and cross-functional projects, providing quality/compliance subject matter expertise.

Job description

Bristol Myers Squibb Co in Dublin is seeking a Senior Manager, Quality Compliance to oversee GMP quality compliance for pharma intermediates, API, drug products and biologics CMOs within External Manufacturing.

The role leads continuous improvement initiatives, acts as Local Process Owner for key Quality Systems, guides major investigations, supports recalls and HA observations, and collaborates with Quality Operations and cross-functional teams to maintain regulatory alignment.