Sr. Director R&D E-Systems & AI Quality
Scorpion Therapeutics, San Francisco, California, United States, 94199
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
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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
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