Senior Manager, GxP Computerized Systems Auditing

This is a fully remote position, open to applicants in United States.

📋 Description

• Create and uphold the global audit strategy for computerized systems and develop a risk-based audit plan for GxP systems.

• Determine audit focus based on system criticality, data integrity risks, regulatory implications, business process dependencies, and historical compliance records.

• Communicate audit trends, systemic risks, and compliance metrics to executive quality governance meetings.

• Define auditor qualification and development criteria while enhancing audit methodologies and effectiveness metrics.

• Organize and oversee internal audits, supplier audits, vendor evaluations, contract organizations, and partner audits related to computerized systems.

• Develop audit plans, conduct interviews, assess objective evidence, document findings, and produce risk-based audit reports.

• Direct audits of software vendors, cloud service providers, SaaS platforms, hosting services, outsourced IT providers, and other external parties.

• Analyze vendor practices in development, testing, validation, release, incident management, change control, cybersecurity, and service management.

• Review third-party compliance concerning regulations, contractual commitments, data integrity expectations, and company procedures.

• Assess the adequacy, effectiveness, and timeliness of corrective and preventive action plans.

• Evaluate adherence to global GxP regulations, guidelines, and industry standards.

• Analyze governance, validation, and compliance controls for emerging technologies, including AI-driven and advanced analytical systems.

• Review cybersecurity measures, vulnerability management, business continuity, disaster recovery, and system resilience initiatives.

• Raise awareness of systemic compliance risks, significant audit outcomes, and recurring control deficiencies.

• Assist with GxP audit initiatives and GxP Health Authority Inspections.

• Act as the process owner for the global computerized systems audit initiative.

• Develop and/or maintain SOPs and work instructions relevant to the GxP audit program.

• Provide guidance, coaching, performance feedback, and skill development for auditors and subject matter experts.

• Undertake additional responsibilities as assigned.

⛳️ Requirements

• A Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality Assurance, or a related field is essential; an advanced degree or relevant professional certification is preferred.

• A minimum of 7 years of experience in computerized systems audits is required with a bachelor's degree, or a Master’s degree with 5+ years of audit experience is preferred.

• At least 5 years of auditing experience with GxP computerized systems, software vendors, cloud service providers, or IT service providers involved in regulated activities is necessary.

• Proven expert-level experience in leading complex audits of computerized systems.

• Experience in conducting internal audits, supplier audits, and/or third-party service provider audits is required.

• Familiarity with health authority inspections, inspection readiness, audit responses, and CAPA evaluations is essential.

• Strong knowledge of GxP computerized systems compliance, including 21 CFR Part 11, EU GMP Annex 11 and Annex 15, ISPE GAMP guidance, validation, Computer Software Assurance, data integrity principles, SDLC, cloud-based GxP applications, IT infrastructure qualification, audit trails, access controls, change control, cybersecurity measures, and risk management principles.

• Robust understanding of relevant U.S., EU, China, and other international GMP/GDP regulations, as well as ICH expectations.

• Proficient in MS Office applications, including Outlook, Word, Excel, and PowerPoint.

• Experience with electronic quality management systems, document management, or audit management platforms is preferred.

• Excellent technical writing, interviewing, communication, stakeholder management, and influencing abilities.

• Capacity to handle multiple priorities in a fast-paced, global, matrixed environment.

• Willingness to travel domestically or internationally up to 25% of the time.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial positions.

• Discretionary equity awards.

• Participation in the Voluntary Employee Stock Purchase Plan.

• Medical coverage.

• Dental insurance.

• Vision coverage.

• 401(k) plan.

• Flexible Spending Account (FSA)/Health Savings Account (HSA).

• Life insurance.

• Paid Time Off.

• Wellness programs.