Senior Manager, GxP Computerized Systems Auditing

BeiGene

20h•$136,500 - $181,500•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality Assurance, or related discipline
7+ years of computerized systems audit experience required OR Master’s degree and 5+ years of computerized systems audit experience preferred
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.
Strong MS Office Skills – Outlook, Word, Excel, and PowerPoint.

Nice To Haves

advanced degree or relevant professional certification preferred
Experience with electronic quality management systems, document management, or audit management platforms preferred.

Responsibilities

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.
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.
Provides leadership to auditors and subject matter experts participating in computerized systems audits, including qualification, coaching, performance input, and development of audit competencies.
Other duties as assigned.