Quality Compliance Senior Manager

Bristol Myers Squibb; Dublin; Sur place; EUR 110 000 - 170 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory inspections experience

Quality management systems

Risk assessment & CAPA

Cross-functional leadership

Pharma industry knowledge

Formation

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

Description du poste

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.

Inspection Readiness & Risk Management

• Maintain permanent Audit readiness across ExM.
• Support self-inspections, internal audits, Health Authority inspections and/or Customer Audits at EXM sites as required.
• Lead or oversee self-inspection activities.
• Support the Policy Evaluation and Regulatory landscape (PEARL) program and Global Reg Observation evaluation (GROe).
• Provide quality oversight of CMOs (API, intermediates, biologics), including, Product Quality Complaints.
• Review/approve QMS documents and maintain controlled Document & Record Management systems.
• Represent ExM Quality on global or Local projects.
• Represent ExM during Health Authority inspections, including preparation activities and on-site support.
• Author responses to Health Authority inspection observations and review responses prepared by CMOs.
• Coordinate and track the annual CMO Risk Assessment (RA), ensuring timely completion.
• Support the development and monitoring of Quality Risk Mitigation Plans based on annual and interim RA triggers.
• Present risk, inspection, and audit trends, issues, and exceptions at ExM Quality Councils.

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 goal 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 commitments 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 escalade compliance risks to senior management.
• Support Annual Product Reviews/APQRs, vendor approvals, bona fides, and stability protocol updates, where applicable.

Key Responsibilities:

• Supports and manages assignments to simplify and improve processes and systems.
• Understands and applies industry regulations knowledge to an understanding of the business operation to achieve regulatory compliance.
• Identifies any gaps in the quality management system (QMS) and takes necessary actions to correct and improve.
• Improves the efficiency of the quality management system (QMS) by managing simplification initiatives throughout the organization.
• Contributes to developing and upholding the company's quality systems and processes.
• Confirms that the quality management system (QMS) aligns with specific regulatory requirements.

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, regulatory sciences, and R&D interfaces.
• In-depth knowledge of cGMP and GDP regulations for the USA, EU, and other international markets.
• Direct experience interacting with Health Authorities (e.g., FDA, EMA) and supporting or leading inspections.
• Direct experience working with external manufacturers and providing quality oversigh