Senior Manager, Quality Compliance, 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

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 gaol setting, performance, and development of team members where applicable.
• Own all elements of the process including relevant procedures/ forms, training materials, share point content, metrics where applicable
• Display technical knowledge of the process and understand risks/weaknesses in the system
• Responsible for ensuring the elements of the process are compliant with Regulatory requirements, Health Authority expectations and with BMS policies/directives where applicable
• Responsible for ensuring the elements of the process are current and reflect current practices
• Be primary subject matter expert for review of regulatory or directive changes, responsible for coordination of input from key stakeholders into the impact assessment to the process
• Regularly review the process (trends metrics, trends observations, right first time (RFT), Design, waste elimination) for their effectiveness and provide feedback to the Quality management team for action and remediation
• Own relevant process issues - speak to trends/issues/exceptions at ExM Quality Councils
• Own Health Authority commits related to the process
• Serve as the subject matter expert in audits / inspections
• Develop and implement pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillance
• Review process performance, lead remediation where needed, and escal compliance risks to senior management.
• Support Annual Product Reviews/APQRs, vendor approvals, bona fides, and stability protocol updates, where applicable.

Qualifications, Knowledge and Skills Required:

• BSc or equivalent in a scientific discipline such as Natural Sciences, Chemistry, Microbiology, Biology, or Pharmacy.
• 8-10+ years' experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory Affairs, or within a Health Authority agency.
• Extensive technical knowledge of chemical, biological, and/or pharmaceutical operations with firsthand experience in manufacturing, quality control, quality assurance, regu