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.
Position Summary
BMS Cruiserath Biologics is seeking to recruit a Manager, QA Technical Operations, Drug Substance, on a fixed term basis.
Reporting to the Senior Manager, QA Technical Operations, Drug Substance, the manager will support investigations within the Multi Product Cell Culture (MPCC) and supporting areas and act as the system owner for the Investigations process at site. The manager QA Technical Operations will also be responsible for supporting qualification and validation activities, as well as New Product Introductions (NPI) and technical transfers. The role will support Engineering, Warehouse, Facilities, Utilities and Automation activities while also providing support for SAP and Manufacturing Execution System (MES).
The role will be both challenging & rewarding and will ensure that the successful candidate can seize a wide range of development opportunities within BMS.
Key Responsibilities
· Investigation system owner for the site with responsibility for MPCC, Warehouse, Automation, Engineering, Facility, Utility and Environmental Monitoring (EM) Investigations.
· Manage the Investigation triage business process and the daily investigations meeting.
· Support global harmonization of the investigations process through BMS network collaboration.
· Act as investigation process SME during Health Authority inspections.
· Act as QA Technical Operations Representative at Investigations Review Board (IRB) and Site Quality Council as required.
· Quality Approver for local and complex multi-site investigations, deviations and subsequent CAPAs, and liaising with other sites/suppliers for complex investigations when required.
· Site Representative at the Global investigations Community of Practice (COP) meetings and Local Process Owner (LPO) meetings.
· Support Implementation of site initiatives to prevent deviation recurrence.
· Promote Right First Time (RFT) approach within investigations process and drive accountability in meeting site investigation KPI’s.
· Act as Senior Manager designee for QA huddles and at cross-functional meetings when required.
· QA Lead for complex change controls, NPI and Tech Transfer Projects.
· QA Lead for cross-functional projects at a site level and site QA representative on global projects.
· Support the maintenance of Maximo, MES and SAP at BMS Cruiserath Biologics.
· Support site validation and qualification activities.
· QA review and approval of Annual Product Quality Review reports (APQRs)
· Support the hiring, development and coaching of key members of the QA Technical Operations team.
· Drive and support a culture of continuous improvement initiatives and safe working practices.
· Review and approval of GMP documentation, including plans, protocols, reports, SOPs, forms, directives, policies and validation documentation as required.
Qualifications & Experience
The successful candidate must possess:
· BSc in Science or a related discipline, with a minimum of 5 years Quality experience in the biopharmaceutical industry.
· Demonstrated knowledge of applicable EU, FDA and other regulatory requirements.
· A strong technical aptitude, global regulatory experience and demonstrated experience interfacing with regulators.
· A thorough understanding of cGMP requirements for areas of responsibility.
· Demonstrated…