Director, R&D Quality Intelligence & Transformation
Bristol Myers Squibb
2 months ago
Remote friendly (Devens, MA)
United States
Operations
Position Summary
The Director, R&D Quality Intelligence & Transformation leads the strategy, build, and adoption of data-driven quality capabilities and innovation across R&D Quality (RDQ), moving RDQ toward proactive, risk-proportionate oversight through high-value analytics, automation, and digital solutions integrated into core quality processes.
Responsibilities
Digital Innovation & Automation
- Lead RDQ Innovation, Digital, and Data Analytics strategies and define a 3–5-year Strategic Roadmap.
- Propose end-to-end digital solutions leveraging AI/ML, robotic process automation, and advanced analytics.
- Lead design and scale-up of digital solutions (e.g., automation bots, remote auditing capabilities, GenAI-assisted reviews) to simplify processes, reduce cycle time, and improve inspection readiness.
- Partner with IT/Analytics teams to ensure data architecture, quality, and lineage support for regulated use cases across GxP domains.
- Facilitate budget planning and forecasting for RDQ Innovative and Digital Capabilities.
Quality Intelligence & Decision Excellence
- Define and own the Quality Intelligence framework for RDQ, including signal detection, trend analytics, and insight-to-action workflows for governance and escalation.
- Establish KPI/OKR frameworks using near real-time data to deliver actionable insights that support RDQ leadership and councils.
Governance, Operating Model & Change Leadership
- Represent RDQ in GQ governance bodies for digital and innovation agendas with measurable follow-through.
- Champion RDQ’s operating model and Future-Ready Quality vision; engage leadership and business functions to cascade context and ways of working.
- Drive adoption via change management, training, and communications aligned with cross-functional engagement.
Stakeholder Engagement & External Benchmarking
- Build trusted partnerships with RDQ/GQ and business functions to co-create insights and decision capabilities.
- Foster a data-driven culture and promote digital/data literacy.
- Manage innovation by experimenting with new digital technologies, scaling capabilities, and collaborating across the enterprise.
- Track external trends and benchmark RDQ/GQ against industry best practices in analytics, GenAI, remote oversight, and risk-based quality.
Qualifications
- Bachelor’s or Master’s degree in Chemistry, Biology, IT, or a health-related field.
- At least 10 years of pharmaceutical/healthcare industry experience, including regulated environments (e.g., Quality Systems, Clinical Development, Pharmacovigilance, or adjacent functions).
- Demonstrated success converting complex challenges into clear action plans and leading large cross-functional initiatives.
- Exceptional cross-functional, matrix, and project leadership skills.
- Strong organizational, analytical, communication, and negotiation skills.
- Demonstrated budgeting/planning experience.
- Proven project management experience including change management, risk management, and crisis management.
- Analytical mindset for business strategy and risk-based decision making.
- Global mindset and inclusive behaviors.
- Ability to operate in ambiguity; strong diplomacy and discretion; maintain confidentiality/security.
- Strong critical thinking; ethical, scientifically sound, cost-effective recommendations consistent with company policy/strategy.
- Computer literacy and ability to function independently in technology-enabled environments (data/analytics tools).
- Preferred: knowledge of GCP/GLP/GVP (and related GxP expectations) and inspection readiness.
- May require travel to local and international site locations.
The Director, R&D Quality Intelligence & Transformation leads the strategy, build, and adoption of data-driven quality capabilities and innovation across R&D Quality (RDQ), moving RDQ toward proactive, risk-proportionate oversight through high-value analytics, automation, and digital solutions integrated into core quality processes.
Responsibilities
Digital Innovation & Automation
- Lead RDQ Innovation, Digital, and Data Analytics strategies and define a 3–5-year Strategic Roadmap.
- Propose end-to-end digital solutions leveraging AI/ML, robotic process automation, and advanced analytics.
- Lead design and scale-up of digital solutions (e.g., automation bots, remote auditing capabilities, GenAI-assisted reviews) to simplify processes, reduce cycle time, and improve inspection readiness.
- Partner with IT/Analytics teams to ensure data architecture, quality, and lineage support for regulated use cases across GxP domains.
- Facilitate budget planning and forecasting for RDQ Innovative and Digital Capabilities.
Quality Intelligence & Decision Excellence
- Define and own the Quality Intelligence framework for RDQ, including signal detection, trend analytics, and insight-to-action workflows for governance and escalation.
- Establish KPI/OKR frameworks using near real-time data to deliver actionable insights that support RDQ leadership and councils.
Governance, Operating Model & Change Leadership
- Represent RDQ in GQ governance bodies for digital and innovation agendas with measurable follow-through.
- Champion RDQ’s operating model and Future-Ready Quality vision; engage leadership and business functions to cascade context and ways of working.
- Drive adoption via change management, training, and communications aligned with cross-functional engagement.
Stakeholder Engagement & External Benchmarking
- Build trusted partnerships with RDQ/GQ and business functions to co-create insights and decision capabilities.
- Foster a data-driven culture and promote digital/data literacy.
- Manage innovation by experimenting with new digital technologies, scaling capabilities, and collaborating across the enterprise.
- Track external trends and benchmark RDQ/GQ against industry best practices in analytics, GenAI, remote oversight, and risk-based quality.
Qualifications
- Bachelor’s or Master’s degree in Chemistry, Biology, IT, or a health-related field.
- At least 10 years of pharmaceutical/healthcare industry experience, including regulated environments (e.g., Quality Systems, Clinical Development, Pharmacovigilance, or adjacent functions).
- Demonstrated success converting complex challenges into clear action plans and leading large cross-functional initiatives.
- Exceptional cross-functional, matrix, and project leadership skills.
- Strong organizational, analytical, communication, and negotiation skills.
- Demonstrated budgeting/planning experience.
- Proven project management experience including change management, risk management, and crisis management.
- Analytical mindset for business strategy and risk-based decision making.
- Global mindset and inclusive behaviors.
- Ability to operate in ambiguity; strong diplomacy and discretion; maintain confidentiality/security.
- Strong critical thinking; ethical, scientifically sound, cost-effective recommendations consistent with company policy/strategy.
- Computer literacy and ability to function independently in technology-enabled environments (data/analytics tools).
- Preferred: knowledge of GCP/GLP/GVP (and related GxP expectations) and inspection readiness.
- May require travel to local and international site locations.