Senior Manager IS Quality and Compliance

Responsibilities

• Act as the Information Sciences (IS) technical lead for Computer System Validation and Computer Software Assurance, providing expert guidance on computerized system compliance across the enterprise.
• Provide technical leadership for Computer System Validation (CSV) and Computer Software Assurance (CSA) activities across GxP computerized systems, ensuring validation strategies align with regulatory requirements, business objectives, and industry best practices.
• Provide guidance on the interpretation and practical application of GxP regulations and industry standards related to computerized systems, electronic records, electronic signatures, and data integrity.
• Provide strategic guidance to project teams on validation approaches, system implementation strategies, and lifecycle compliance to ensure consistent application of risk-based validation principles.
• Provide technical leadership and mentoring to project teams on CSV, CSA, and GxP computerized system compliance.
• Partner with Information Sciences (IS), System Owners, Business Owners, and Quality to develop validation strategies, assess compliance requirements, and ensure validation activities are planned and executed in accordance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, CSA principles, and internal procedures.
• Lead the development, review, and approval of validation lifecycle deliverables, including validation plans, risk assessments, requirements, testing documentation, traceability, reports, data migration, and system retirement documentation.
• Author and continuously improve CSV procedures, templates, and lifecycle methodologies to support efficient, risk-based validation practices.
• Partner with Quality, System Owners, Business Process Owners, and System Administrators to assess computerized systems for GxP impact and ensure appropriate validation and compliance controls are implemented.
• Lead CSV-related deviations, investigations, CAPAs, change controls, and periodic reviews for assigned GxP systems.
• Serve as the primary IS subject matter expert for CSV, CSA, Data Integrity, electronic records and signatures (21 CFR Part 11), and computerized system lifecycle compliance.
• Conduct data integrity assessments, audit trail reviews, and access control reviews to ensure compliance with ALCOA+ principles and regulatory expectations.
• Lead cross-functional initiatives to advance Computer Software Assurance (CSA), enhance risk-based validation practices, and continuously improve the GxP computerized system lifecycle.
• Maintain the IS Quality System Inventory while developing quality metrics, trend analyses, and continuous improvement initiatives to strengthen the computerized system compliance program.

Requirements

• Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, or related discipline.
• Minimum 10 years of experience supporting GxP computerized systems in the pharmaceutical or biotechnology industry.
• Demonstrated expertise in Computer System Validation (CSV), Computer Software Assurance (CSA), and computerized system lifecycle management within regulated environments.
• Strong working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity, ALCOA+, and software development lifecycle methodologies.
• Demonstrated ability to lead multiple complex validation projects simultaneously.
• Experience supporting regulatory inspections and audit readiness activities.
• Experience with cloud-based/SaaS GxP applications and risk-based validation approaches.
• Excellent communication, collaboration, and problem-solving skills with the ability to influence cross-functional stakeholders.
• Results-oriented with the capacity to execute projects with minimal supervision.
• Attention to detail and quality.

Qualifications

• Commercial pharmaceutical or biotechnology experience.

Skills

• Experience supporting enterprise GxP applications (e.g., Quality, Regulatory, Clinical, Supply Chain, ERP, and Document Management systems such as Veeva, DocuBridge, Trial Interactive eTMF, NetSuite, TraceLink, etc.).
• Experience supporting AI-enabled or emerging digital technologies in regulated environments.
• Knowledge of IT security frameworks such as NIST, ISO/IEC 27001, SOC 2.
• Familiarity with privacy and financial regulations such as GDPR, HIPAA, Sarbanes-Osley (SOX).