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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 rich in diversity. 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 .

The Senior Director, Risk Based Quality Management leader will work closely with the R&D Quality GxP Heads as well as Global Quality, R&D, and Enterprise Risk functons to manage and communicate risks and mitigations to respective management boards. This role is a key contributor in advancing our overall Global Quality vision and strategy.

Qualifications & Experience

• Minimum of BA/BS degree or in a life science discipline; advanced education preferred

• Minimum 15 years Quality experience or relevant BioPharma experience, with demonstrated experience in R&D and R&D Quality roles.

• Experience in quality risk management and the application of Quality by Design in clinical trials.

• Knowledge and experience in GxP global regulations necessary for appropriate strategy setting, decision making, and quality oversight to ensure BMS complies with regulatory requirements.

• Previous experience dealing with regulatory agencies in policy development, inspections, investigations, and audits.

• Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management.

• Ability to develop/translate long-range strategic plans into short-range operational processes/systems/goals and ability to make sound decisions/recommendations with global perspective

• Experience in managing teams, providing coaching, development and mentoring to employees.

• Understands the big picture, beyond their own functional area. Enterprise thinker.

• Broad understanding of digital and data, including AI, automation, advanced analytics, etc.

• Proven problem-solving skills to prevent and overcome complex process and quality related issues

• Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication.

• Embraces complexity but strives for simplicity. Keen focus on phase appropriate and risk based scientific decision making

• Creates a vision for the future by spotting strategic opportunities for breakthrough performance. Translates the case for change into actionable plans for the organization.

• Demonstrates smart risk-taking and personal resilience when implementing change. Enables others to navigate change with confidence and in sustainable ways.

Key Responsibilities:

Clinical Trial Quality by Design (QbD), Risk Identification and Management

• Define, own, and execute R&D Quality processes contributing to Drug Development's end to end Risk Based Management (RBM) framework across the clinical trial portfolio. This includes collaborating with clinical trial teams, providing R&D Quality expertise, critical thinking, and quality inputs as part of the upstream protocol authoring process to:

• Identify critical to quality (CtQ) data, processes and vendors

• Identify risks to CtQ factors, develop mitigations and design them into protocols and operational plans [Quality by Design (QbD)]. This includes providing quality and compliance insights from audits, inspections, internal quality events/significant issues, and external intelligence to inform QbD.

• Assisting the business in defining and establishing Acceptable Ranges and Thresholds for CtQ data.

• Support the monitoring and evaluation of CtQ factors throughout the study lifecycle and adapt operational and quality plans accordingly.

• Provide quality and compliance consultation to clinical trials teams throughout study lifecyle.

• Ensure effective management of significant quality issues/non compliance and important protocol deviations for CtQ data, processes and vendors

• Lead and author the overall Quality Narrative (or equivalent) to document the end to end risk based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management. This involves collecting all the relevant inputs from the RBM framework as well as R&D Quality Clinical Quality inputs from audit and inspection.

• In partnership with the business and other R&D Quality functions, ensure outputs of RBM are effectively communicated to quality councils/risk committees.

• Ensure compliance with ICH E8 and E6.

• Partner with Drug Development to deliver training and education (e.g., use cases, best practices, road shows, etc.) to support effective RBM practices.

• Drive continuous improvement by establishing feedback loops to incorporate lessons learned into future trials.

Quality and Compliance Governance and Risk Management/Reporting

• Provide R&D Quality Leadership in developing and sustaining an effective quality and compliance govervance model across nonclinical, clinical and pharmacovigilance in line with Global Quality.

• Drive the effective management of R&D Quality Councils across nonclinical, clinical and pharmacovigilance (R&D Quality Chair and Accountability reside with R&D GxP Quality Head) ensuring rigor in meeting, action, and documentation.

• Lead the development and delivery of meaningful data and information for R&D Quality council oversight, ensuring a risk based and data driven approach.

• Drives ongoing quality risks assessment and evaluation of strategic and operational risk in RDQ in collaboration with R&D Quality GxP Teams.

• Lead the roll up of R&D GxP Quality risks and insights for reporting to Global Quality Councils, Enterprise Risk Committees, and overall Global Quality Risk Management Framework.

• For Clinical, lead the Serious Breach Committee focused on ensuring rigor in meeting, action, and documentation to support effective decision making and reporting according to local requirements.

Deviation and CAPA Management

• Responsible for providing R&D Quality central expertise and support for managing CAPAs from deviations, audits, inspections, and quality events.

• Deliver expert root cause analysis capabilities in support of significant quality issue investigations and action plans.

• Provide CAPA oversight, ensuring clear tracking and metrics to drive on time performance.

• Contribute to continuously evaluating and improving the CAPA process aimed at driving effectiveness and simplification.

R&D Quality Operations and Performance Management

• Provide coordination and support for R&D Quality Leadership Team meetings, ensuring rigor in cadence, agenda, actions and follow-up.

• Act as main point of contact for Global Quality Strategy and Business Excellence (SBE), ensuring RDQ delivers on Global Quality strategies and initiatives.

• In collaboration with the R&D Quality Leadership Team, leads the development of the overall R&D Quality strategy and roadmap focused on pipeline, performance and people.

• Leads the development and oversight of R&D Quality performance metrics and ensures effective roll up and communication to GQ/GPS/R&D as applicable.

• Support the oversight and management of R&D Quality Budget and Headcount.

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 an inclusive culture, promoting diversity 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 a diverse 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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.

Company: Bristol-Myers Squibb

Req Number: R1585268

Updated: 2024-09-17 04:22:41.420 UTC

Location: Princeton-NJ

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.