Director, Quality Risk Management

Bristol-Myers Squibb; Princeton (NJ); On-site; USD 187,000 - 228,000; Full time

Job summary

Bristol-Myers Squibb is seeking a Director of Quality Risk Management to lead strategic initiatives that ensure compliance and efficiency within the Quality Risk Management framework. This role involves driving process optimization, stakeholder engagement, and the integration of innovative digital solutions to enhance risk management capabilities and foster a culture of safety and awareness across the organization.

Benefits

Medical, pharmacy, dental and vision care

401(K) plan

Paid vacation and paid holidays

Employee assistance programs

Tuition reimbursement

Qualifications

• 15 years of biopharmaceutical/pharmaceutical industry experience.
• At least 3 years in a risk management leadership position.
• Expertise in GMP compliance and Quality System.

Responsibilities

• Provide strategic leadership for QRM programs.
• Drive process design and improvement of QRM procedures.
• Collaborate with stakeholders for effective risk management.

Skills

Leadership

Risk Management

Communication

Problem Solving

Collaboration

Analytical Skills

Education

Master's degree in pharmaceutical sciences, engineering, biology, or related discipline

Job description

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 audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.
• Oversee the process design for managing major disruptions to the GxP business including how to respond in a Risk Based manner (incorporating QRM principles, tools and processes into the response)
• Provide leadership, coaching, and training for members of the QRM Community of Practice and other QRM practitioners including both the technical processes and the behaviors necessary to optimize process execution.
• Support the testing and roll out of IT systems supporting QRM processes and data analytics.

Qualifications & Experience:

• Master's degree in pharmaceutical sciences, engineering, biology, or other related discipline or equivalent combination of education and experience.
• A minimum of 15 years of biopharmaceutical/pharmaceutical industry experience with at least 3 years in risk management leadership position.
• Expertise in GMP compliance, Quality System and global GMP regulations
• Must have strong knowledge and expert understanding using different QRM tools for the different GXP areas (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP).
• Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
• Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
• Demonstrated influential leadership expertise and experience with senior level interactions.
• Excellent analytical and problem-solving skills, with the ability to identify and mitigate risks effectively
• Enterprise mindset to be able to think and act across functions and divisions.
• Ability to work in a fast-paced and dynamic environment, managing multiple priorities simultaneously.
• Strong leadership and project management skills, with the ability to lead cross-functional teams.
• Expert-level knowledge and experience using data to drive understanding, decisions, and recommendations.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with stakeholders at all levels.
• Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
• Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk to deliver value added business results that meet high quality requirements with tight deadlines.
• Travel: Ability to travel 10-25% as needed

GPS_2025 GQ_2025

The starting compensation for this job is a range from $187,700 to $227,400, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

#LI-Hybrid

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.