Director, Quality Risk Management

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary
The Director, Quality Risk Management will drive consistent Global Leadership on Quality Risk Management (QRM), the Risk Management Framework, Risk Posture considerations and provide support for key QRM processes within the GxPs (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP) across the Product Lifecycle. Accountable to drive QRM process optimization, integration, adoption and continuous improvement through capability building, key stakeholder engagement, digital enhancement, trend analysis of QRM data and guidance on authoring QRM procedures. Works cross-functionally to develop performance improvement initiatives throughout the organization by interacting and working with many great teams and leaders across the BMS network.

This position will report into the Senior Director, Risk Management.

Key Responsibilities:

• Provide strategic and tactical leadership for establishing and maintaining robust QRM programs across the BMS QMS Level 1 and 2 processes and sub-processes, end-to-end product lifecycle and across all BMS in alignment with relevant governmental regulations and guidelines.

• Drive process design, simplification, deployment, maintenance, monitoring and improvement of QRM procedures and methodologies (tools). Provide oversight for the management of all changes being planned and executed in these processes.

• In partnership with the Senior Director, Risk Management, champion the E2E, across product lifecycle QRM Framework and strategic roadmap.

• Develop and Drive enhancement on digital QRM mapping. Lead execution digital roadmap.

• Develop Risk Tolerance statements, risk acceptance statements and guiding principles for BMS QRM related risk posture.

• Lead Risk identification and risk communication/reporting for governance meetings, such as Quality management reviews and Enterprise Risk Management and support managing emerging risks to support business objectives.

• Lead and support to teams in implementing risk management capabilities and process elements

• Provide guidance and coaching for the Risk Management Team.

• Lead the QRM training framework and certification program design & oversee deployment.

• Foster a culture of risk awareness, risk informed decision making and proactive risk management throughout the organization and by this enhance QRM maturity.

• Stakeholder Partnering and Engagement: Lead the partnership with teams across BMS for stakeholder-oriented incorporation/improvement of QRM principles and appropriate risk-based approaches into the business processes of the Quality Management System enterprise-wide.

• Co-chair with the Senior Director, Risk Management, QRM specific governance and oversight forums.

• Business support: Drive process monitoring/adoption and GxP risk profiles through overseeing data collection, analysis, trending and reporting of QRM dashboards in collaboration with I&T .

• Stay updated with industry best practices and regulatory requirements related to QRM communicate within BMS and adapt internal processes effectively.

• Works across regulator/industry boundaries to become a QRM industry leader, find common solutions, and drive positive impact and benefits for patients.

• Collaborate with internal and external stakeholders to ensure alignment and compliance with QRM processes.

• Provide direction and critical input for setting metrics and monitoring and evaluating the effectiveness of QRM initiatives, and recommend improvements as needed.

• Support site and function teams during regulatory inspections or a