Global Quality Compliance Leader, External Manufacturing

Bristol Myers Squibb; Dublin; On-site; EUR 120,000 - 150,000; Full time

Job summary

Bristol Myers Squibb in Ireland seeks a Senior Manager, Quality Compliance to oversee quality compliance for pharma intermediates, API, drug product finished goods, and biologics CMOs within External Manufacturing. The role drives Quality Systems compliance across the global ExM network and supports MAHs, TPcs, and regulatory interactions.

You will lead continuous improvement, manage major investigations, issue HA notifications when required, and ensure cGMP adherence across the organization.

Qualifications

• BSc or equivalent in a scientific discipline.
• 8-10+ years' pharma experience, preferably in Quality/Regulatory.
• Extensive knowledge of chemical/biological/pharma operations and GMP.

Responsibilities

• Lead Continuous Improvement and Compliance projects for External Manufacturing.
• Serve as Local Process Owner for Quality Systems (Change Control, Deviations, CAPA, Complaints).
• Lead FIT/FIRM processes for major investigations and present to senior management.
• Support PAC recalls and HA notifications where required.
• Provide quality/compliance support to Quality Operations Managers.
• Review HA observations and ensure regulatory alignment.
• Draft and review SOPs and controlled documents for cGMP compliance.
• Represent ExM on global quality teams and cross-functional projects.

Skills

Quality compliance

CAPA

Change Control

GMP knowledge

Regulatory liaison

Project leadership

Education

BSc or equivalent in a scientific discipline

Job description

Bristol Myers Squibb in Ireland seeks a Senior Manager, Quality Compliance to oversee quality compliance for pharma intermediates, API, drug product finished goods, and biologics CMOs within External Manufacturing. The role drives Quality Systems compliance across the global ExM network and supports MAHs, TPcs, and regulatory interactions.

You will lead continuous improvement, manage major investigations, issue HA notifications when required, and ensure cGMP adherence across the organization.