Senior Manager, GxP Computerized Systems Auditing
$136,500–$181,500 year
RemoteUnited States
Job Summary
Develop and maintain the global computerized systems audit strategy and risk-based audit plan for GxP-regulated environments supporting clinical, manufacturing, laboratory, quality, regulatory, and pharmacovigilance processes. Lead internal, supplier, vendor, contract organization, and partner audits involving computerized systems and associated service providers, including software vendors, cloud providers, and outsourced IT services. Prepare audit plans, conduct interviews, review objective evidence, document observations, and issue clear, risk-based audit reports while evaluating corrective and preventive action plans for adequacy and effectiveness. Present audit trends, systemic risks, and compliance metrics to executive quality governance forums and support GxP Health Authority Inspections as required. Provide leadership to auditors and subject matter experts, including qualification, coaching, and performance input, while developing and maintaining SOPs pertinent to the audit program.
Required Qualifications
- Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality Assurance, or related discipline
- 7+ years of computerized systems audit experience
- Master's degree and 5+ years of computerized systems audit experience
- Strong working knowledge of GxP computerized systems compliance, including 21 CFR Part 11, EU GMP Annex 11 and Annex 15, ISPE GAMP guidance, computerized system validation, Computer Software Assurance, data integrity principles, SDLC, cloud-hosted GxP applications, IT infrastructure qualification, audit trail review, access controls, change control, cybersecurity controls impacting regulated systems, and risk management principles
- Minimum of 5 years of experience auditing GxP computerized systems, software vendors, cloud service providers, or IT service providers supporting regulated activities
- Demonstrated expert-level experience leading complex computerized systems audits
- Experience leading internal audits, supplier audits, and/or third-party service provider audits
- Experience supporting health authority inspections, inspection readiness activities, audit responses, and CAPA evaluation
- Strong understanding of applicable U.S., EU, China, and other global GMP/GDP requirements, as well as ICH expectations relevant to global clinical and commercial operations
- Strong technical writing, interviewing, communication, stakeholder management, and influencing skills
- Ability to manage multiple priorities in a fast-paced, global, matrixed environment
- May require up to 25% travel, domestic or international
Desired Qualifications
- Advanced degree or relevant professional certification
- Experience with electronic quality management systems, document management, or audit management platforms
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