Senior Manager, Quality Compliance, 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

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.

The Senior Manager, Quality Compliance provides quality compliance oversight for pharma (intermediates, API and drug product/finished goods), and biologics CMOs within External Manufacturing. The position also drives effective implementation and continuous improvement of Quality Systems' compliance across the Global External Manufacturing network. In addition, the role provides comprehensive quality and compliance support to Quality operations, Alliance Partners, Third-Party Customers/Contractors (TPCs/TPMs), and Marketing Authorization Holders (MAHs) to ensure BMS Good Manufacturing Practices (GMP) and regulatory standards are consistently met. The Senior Manager is also responsible for effective implementation of Quality Systems and Training across Global External Manufacturing.

Specific Responsibilities of this role:

• Lead Continuous Improvement and/or Compliance projects supporting the External Manufacturing (ExM) or network.
• Serve as Local Process Owner with responsibility for assigned Quality Systems (e.g., Change Control, Deviations, CAPA, Complaints), ensuring procedures, training, metrics, and compliance are maintained.
• Lead the BMS Fact Finding Information Team (FIT) and Fact-Finding Information Review Meeting (FIRM) processes for major investigations involving ExM manufacture.
• Prepare and present the information to senior management in support of the FIT / FIRM processes.
• Support the Product Action Committee (PAC) process for all recalls associated with CMOs managed by ExM Support issuance of HA notifications (e.g. Field Alert Reports) where required.
• Provide quality/compliance support to the Quality Operations Managers.
• Raise Notifications to Management (NTMs) for major and critical investigations where required.
• Review and approve responses to Health Authority (HA) observations prepared by CMOs to ensure regulatory alignment.
• Write and/or review Standard Operating Procedures (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.

In addition, the Senior Manager, ExM Quality Compliance will:

• Where applicable, lead and develop direct reports; build a high-performance team culture and strong cross-functional relationships.
• Manage