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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 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.
- 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 ProtocolBMS 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.
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