Associate Director, IS Quality and Compliance

The Opportunity:

Revolution Medicines is seeking an experienced leader with a pharmaceutical quality assurance and Computer System Validation background to serve as Associate Director, IS Quality and Compliance within the Information Sciences organization. This hands-on leadership role is responsible for the operational leadership and oversight of GxP computerized system compliance across Information Sciences. The Associate Director will lead and mature risk-based Computer Software Assurance practices, oversee a portfolio of complex validation initiatives, develop team members and external resources, and partner with Quality and business stakeholders to maintain inspection readiness and regulatory compliance.

This position reports to the Senior Director, IS Quality, Risk & Compliance.

Responsibilities:

• Lead the day-to-day IS Computer System Validation (CSV) program, translating departmental direction into operating priorities, execution plans, and measurable outcomes.

• Serve as the primary IS technical and operational lead for CSV, CSA, data integrity, electronic records and signatures, and computerized system lifecycle compliance.

• Provide leadership and oversight for CSV/CSA activities across GxP computerized systems, ensuring validation strategies align with regulatory requirements, business objectives, approved policies, and industry practices.

• Interpret and provide practical guidance on GxP regulations and industry standards related to computerized systems, electronic records, electronic signatures, and data integrity. Escalate significant risks or policy decisions to the Senior Director.

• Direct project teams in developing risk-based validation approaches and system implementation strategies for enterprise applications, cloud and SaaS solutions, infrastructure, integrations, data migrations, and system retirements.

• Lead and mentor employees, consultants, and project resources supporting CSV and computerized system compliance. Coordinate workloads, establish delivery expectations, and provide technical coaching and feedback.

• Partner with IS, System Owners, Business Owners, Business Process Owners, and Quality to assess compliance requirements and ensure validation activities are appropriately planned, resourced, and executed.

• Oversee the development, review, and approval of validation lifecycle deliverables, including validation plans, risk assessments, requirements, testing documentation, traceability, reports, data migration documentation, periodic reviews, and system retirement documentation.

• Lead the development and continuous improvement of CSV procedures, templates, training, and lifecycle methodologies within the approved quality-management framework.

• Provide operational oversight for CSV-related deviations, investigations, CAPAs, change controls, and periodic reviews. Ensure timely closure, assess effectiveness, and escalate significant compliance concerns.

• Oversee data integrity assessments, audit-trail reviews, access-control reviews, and electronic-signature assessments to ensure compliance with ALCOA+ principles and regulatory expectations.

• Lead cross-functional initiatives to strengthen risk-based validation practices and improve the efficiency and effectiveness of the GxP computerized system lifecycle.

• Coordinate IS inspection and audit-readiness activities, including evidence collection, subject-matter-expert preparation, request tracking, and assigned remediation activities. Support inspection and audit responses under Senior Director oversight.

• Oversee the IS Quality System Inventory and system-characterization process, ensuring accurate GxP classification, complete records, effective intake controls, and timely lifecycle reviews.

• Develop quality metrics, trend analyses, and program reporting. Identify emerging risks and recommend corrective actions, resource adjustments, or continuous-improvement initiatives to the Senior Director.

• Monitor evolving regulatory expectations, industry trends, and emerging technologies, evaluate their operational impact, and recommend appropriate improvements to validation practices and controls.

Required Skills, Experience and Education

• Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, or a related discipline; advanced degree preferred.

• Minimum 12 years of progressive experience supporting GxP computerized systems in the pharmaceutical or biotechnology industry.

• Demonstrated expertise in CSV/CSA, data integrity, quality risk management, and computerized system lifecycle management within regulated environments.

• Strong working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+, and software development lifecycle methodologies.

• Demonstrated experience leading complex, cross-functional or multi-region validation and compliance programs.

• Experience managing, mentoring, or providing work direction to employees, consultants, vendors, or project teams.

• Demonstrated ability to oversee multiple complex validation initiatives, establish priorities, coordinate resources, and deliver results across competing timelines.

• Experience supporting regulatory inspections, internal and external audits, remediation activities, and ongoing inspection readiness.

• Experience with cloud-based and SaaS GxP applications, infrastructure qualification, enterprise integrations, and risk-based validation approaches.

• Excellent communication, collaboration, and problem-solving skills, with the ability to influence cross-functional stakeholders and communicate effectively with senior leaders.

• Results-oriented, with sound judgment, attention to detail, and the ability to operate with a high degree of independence.

Preferred Skills:

• Experience establishing or maturing a CSV/CSA Center of Excellence program.

• Experience supporting enterprise Quality, Regulatory, Clinical, Supply Chain, ERP, and Document Management applications, including platforms such as Veeva, DocuBridge, Trial Interactive eTMF, NetSuite, TraceLink, or comparable systems.

• Experience with regulated infrastructure, cloud services, system integrations, backup and recovery, or business-continuity compliance.

• Experience leading multinational initiatives and working across regions, cultures, and time zones.

• Experience supporting AI-enabled or other emerging digital technologies in regulated environments.

• Knowledge of IT security and assurance frameworks such as NIST, ISO/IEC 27001, and SOC 2, with familiarity with GDPR, HIPAA, SOX, or similar requirements.

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