Sr. Director R&D E-Systems & AI Quality

Role Summary

The Senior Director, R&D E-Systems & AI Quality leads Electronic Systems and Artificial Intelligence Quality activities for the Development organization within R&D Quality. You will define and execute the Quality Digital & Controls Strategy, address implications of AI, ML, RPA, and other digital tools, and build partnerships across Development, IT, and other functions while elevating Quality as a trusted advisor. The role requires influencing cross-functional stakeholders and modernizing Quality & Compliance practices to novel technologies.

Responsibilities

• Define and execute the Quality strategy for Development Electronic Systems including the use of AI, establishing standards, goals, and a long-term roadmap that ensures compliance, data integrity, and business enablement
• Enable adoption of emerging technologies (e.g., RPA, AI, ML, LLMs) by embedding fit-for-purpose quality controls into processes to drive innovation while ensuring compliance, efficiency, and quality
• Champion automation and digital solutions to enable CSV/CSA activities and increase transparency
• Drive a risk-based approach to validation and eSystem data integrity
• Partner with IT and Business functions to modernize E-Systems Quality and align with evolving regulatory landscape
• Unify Electronic Systems policies and procedures across PDM, Commercial, and IT
• Lead and facilitate change management strategy and activities related to strategy and process change

Responsibilities (Operational Excellence and Oversight)

• Oversee Development systems and applications, including use of AI and ML for Development
• Advise in cross-functional governance to ensure Quality is a key consideration in technology initiatives
• Support the R&D Data Governance Council with focus on Data Integrity, Privacy and Protection
• Serve as Development Global Process Owner for E-systems Quality (process, issues, risks, inspection and audit requests)
• Identify and implement process improvements to enhance output and efficiency of E-System compliance
• Define and implement metrics to measure E-Systems Quality performance, increasing transparency and accountability
• Oversee Development QA activities, including testing, validation, and risk management in line with CSA principles
• Ensure data privacy and security compliance and maintain high data integrity
• Anticipate and mitigate risks across the Development E-Systems portfolio, resolve delivery roadblocks, and align stakeholders
• Use data-driven insights to analyze CAPAs, deviations, and quality events to identify systemic issues and actionable improvements
• Maintain continuous audit readiness for Development E-Systems and provide efficient audit support
• Review, assess, and defend critical audit observations related to E-Systems in Development
• Manage vendor relationships and ensure cost-effective, value-aligned execution
• Drive accountability for SaaS vendor-managed eSystems in a validated and compliant state, aligning with data integrity standards
• Shape enterprise-level strategies to mitigate risk, strengthen regulatory readiness, and enhance data governance and system resilience

Qualifications

• Deep understanding of R&D/Development system/application quality assurance methodologies, testing techniques, and risk management
• Strong familiarity with R&D electronic systems regulations and standards, including GxP in biopharmaceuticals
• Proven ability to lead and motivate a team, provide guidance, and drive change
• Ability to identify and resolve complex quality and compliance issues
• Understanding of and experience with change management principles
• Bachelor of Science or Arts degree; advanced degree preferred
• 13+ years of pharmaceutical industry IT and/or Development experience
• Excellent written and oral communication skills
• Experience managing external vendors and overseeing budgets
• Ability to develop and manage cross-functional relationships across R&D
• Applied knowledge of performance measurements (metrics, dashboards)
• Proven ability to delegate in a matrix environment, anticipate risks, and solve problems
• Strong leadership presence with ability to influence programs without direct authority
• Strong EQ and interpersonal skills with understanding of team dynamics
• Strong negotiation and conflict resolution skills
• Ability to make hard decisions impacting staff
• When needed, ability to travel

Skills

• Digital tool adoption (AI, ML, RPA) and innovation enablement in regulated environments
• Cross-functional collaboration and stakeholder influence
• Change leadership and culture transformation
• Risk-based thinking and simplified regulatory processes
• Lean continuous improvement and SOP harmonization
• Data governance, privacy, and data integrity principles
• Quality assurance testing, validation, and CSA competencies
• Vendor management and budget oversight

Education

• Bachelor’s degree required; advanced degree preferred

Additional Requirements

• Travel as needed