Summary by IrelandJobHub
Bristol-Myers Squibb Co seeks a Senior Manager for Quality Compliance in External Manufacturing. The role oversees quality systems for pharma and biologics contract manufacturers. Responsibilities include leading continuous improvement projects and managing quality system processes like change control and deviations. The manager supports quality operations, alliance partners, and third-party customers to ensure Good Manufacturing Practices compliance. Additionally, the position involves representing the department on global quality teams and providing subject matter expertise.
Role Overview
Bristol-Myers Squibb Co requires a Senior Manager to provide quality compliance oversight for external manufacturing activities. This position covers pharmaceutical intermediates, active pharmaceutical ingredients, and biologics produced by contract manufacturing organisations. The individual drives the implementation and continuous improvement of quality systems across the global network. Comprehensive support is offered to quality operations, alliance partners, and third-party customers to ensure adherence to Good Manufacturing Practices and regulatory standards.
Key Responsibilities
The manager leads continuous improvement and compliance projects within the external manufacturing network. As a local process owner, they maintain procedures and metrics for quality systems such as change control, deviations, and corrective actions. The role involves leading fact-finding teams for major investigations and presenting findings to senior management. Additionally, the individual supports product action committees during recalls and reviews responses to health authority observations.
Documentation and Representation
Writing and reviewing standard operating procedures ensures compliance with company standards and current Good Manufacturing Practice requirements. The manager represents the external manufacturing department on global quality teams and cross-functional initiatives. They provide subject matter expertise to support various quality and compliance efforts. The position also involves raising notifications to management for critical investigations where necessary.
Leadership and Development
Where applicable, the senior manager leads and develops direct reports to build a high-performance team culture. Strong cross-functional relationships are established to support effective collaboration. The role requires fostering an environment that values inclusion and wellbeing. The individual contributes to a supportive environment that offers opportunities for growth and meaningful work.