Senior Manager, GxP Computerized Systems Auditing

General Description:

The Senior Manager, GxP Computerized Systems Auditing, is responsible for managing and executing a risk-based audit program for computerized systems used in GxP-regulated environments. This role provides independent quality oversight of computerized systems throughout their lifecycle through audits of validation, change management, data integrity controls, cybersecurity governance, vendor oversight, electronic records and signatures compliance, and system operations. The individual serves as a subject matter expert in GxP computerized systems compliance and partners with Quality, IT, Manufacturing, Clinical, Regulatory, and third-party service providers to assess compliance risks, identify control gaps, support inspection readiness, and drive sustainable corrective and preventive actions.

This role requires strong technical judgment, regulatory expertise, cross-functional influence, and the ability to make risk-based decisions in support of global quality compliance objectives.

• Develop and maintain the global computerized systems audit strategy and risk-based audit plan for GxP computerized systems supporting clinical, manufacturing, laboratory, quality, regulatory, and pharmacovigilance processes.
• Prioritize audit coverage based on system criticality, data integrity risk, regulatory impact, business process dependency, and prior compliance history.
• Present audit trends, systemic risks, and compliance metrics to executive quality governance forums.
• Establish qualification and development requirements for auditors performing computerized systems audits.
• Support continuous improvement of global audit methodology and audit effectiveness metrics.
• Plan and lead internal, supplier, vendor, contract organization, and partner audits involving computerized systems and associated service providers.
• Prepare audit plans, conduct interviews, review objective evidence, document observations, and issue clear, risk-based audit reports.
• Lead audits of software vendors, cloud service providers, SaaS platforms, hosting providers, outsourced IT service providers, and other third parties supporting GxP processes.
• Evaluate vendor development, testing, validation, release, incident, change control, cybersecurity, and service management practices.
• Assess third-party compliance with applicable regulatory requirements, contractual obligations, data integrity expectations, and company procedures.
• Evaluate corrective and preventive action plans for adequacy, effectiveness, and timely completion.
• Assess compliance with applicable global GxP regulations, guidance, and industry standards, including 21 CFR Part 11 and applicable FDA GxP regulations, EU GMP Annex 11 and Annex 15, PIC/S guidance, MHRA and WHO data integrity expectations, and ISPE GAMP guidance.
• Evaluate governance, validation, and compliance controls associated with emerging technologies, including artificial intelligence-enabled and advanced analytics systems supporting regulated activities.
• Evaluate cybersecurity controls, vulnerability management, business continuity, disaster recovery, and system resilience programs impacting GxP computerized systems.
• Systems within scope may include, but are not limited to, LIMS, eQMS, MES, ERP, E , CTMS, EDC, pharmacovigilance systems, document management systems, infrastructure platforms, integration platforms, automated workflow technologies, data repositories, analytics platforms, data integrity tools, and cloud-hosted applications supporting GxP processes.
• Escalate systemic compliance risks, significant audit findings, and recurring control weaknesses to appropriate quality governance forums and business stakeholders.
• Support GxP audit programs as required.
• Support GxP Health Authority Inspections as required.
• Serve as process owner for the global computerized systems audit program, including governance, performance monitoring, continuous improvement, and alignment with enterprise risk management priorities.
• Develop and/or maintain SOPs and work instructions pertinent to the GxP audit program.
• Other duties as assigned.

• Provides leadership to auditors and…