Bristol Myers Squibb
Senior Director, Risk Governance and Operations, R&D Quality
Bristol Myers Squibb, Summit, New Jersey, us, 07902
Working with UsChallenging. 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.
Position OverviewThe 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 functions 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 preferredMinimum 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.Collaborate with clinical trial teams, providing R&D Quality expertise, critical thinking, and quality inputs as part of the upstream protocol authoring process.Identify critical to quality (CtQ) data, processes and vendors.Identify risks to CtQ factors, develop mitigations and design them into protocols and operational plans.Support the monitoring and evaluation of CtQ factors throughout the study lifecycle.
Provide quality and compliance consultation to clinical trials teams throughout study lifecycle.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 to document the end to end risk based quality management for CtQ data, processes and vendors.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 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 governance model across nonclinical, clinical and pharmacovigilance.Drive the effective management of R&D Quality Councils ensuring rigor in meeting, action, and documentation.Lead the development and delivery of meaningful data and information for R&D Quality council oversight.Drive ongoing quality risks assessment and evaluation of strategic and operational risk in RDQ.Lead the roll up of R&D GxP Quality risks and insights for reporting to Global Quality Councils.Lead the Serious Breach Committee focused on ensuring rigor in meeting, action, and documentation.Deviation and CAPA Management
Provide 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.Act as main point of contact for Global Quality Strategy and Business Excellence (SBE).In collaboration with the R&D Quality Leadership Team, leads the development of the overall R&D Quality strategy and roadmap.Leads the development and oversight of R&D Quality performance metrics.Support the oversight and management of R&D Quality Budget and Headcount.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.
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. 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.
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.#J-18808-Ljbffr
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.
Position OverviewThe 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 functions 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 preferredMinimum 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.Collaborate with clinical trial teams, providing R&D Quality expertise, critical thinking, and quality inputs as part of the upstream protocol authoring process.Identify critical to quality (CtQ) data, processes and vendors.Identify risks to CtQ factors, develop mitigations and design them into protocols and operational plans.Support the monitoring and evaluation of CtQ factors throughout the study lifecycle.
Provide quality and compliance consultation to clinical trials teams throughout study lifecycle.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 to document the end to end risk based quality management for CtQ data, processes and vendors.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 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 governance model across nonclinical, clinical and pharmacovigilance.Drive the effective management of R&D Quality Councils ensuring rigor in meeting, action, and documentation.Lead the development and delivery of meaningful data and information for R&D Quality council oversight.Drive ongoing quality risks assessment and evaluation of strategic and operational risk in RDQ.Lead the roll up of R&D GxP Quality risks and insights for reporting to Global Quality Councils.Lead the Serious Breach Committee focused on ensuring rigor in meeting, action, and documentation.Deviation and CAPA Management
Provide 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.Act as main point of contact for Global Quality Strategy and Business Excellence (SBE).In collaboration with the R&D Quality Leadership Team, leads the development of the overall R&D Quality strategy and roadmap.Leads the development and oversight of R&D Quality performance metrics.Support the oversight and management of R&D Quality Budget and Headcount.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.
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. 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.
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.#J-18808-Ljbffr