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United States
Remote only
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
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.
Essential Functions of the Job:
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, EBR, 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.
Supervisory Responsibilities:
Provides leadership to auditors and subject matter experts participating in computerized systems audits, including qualification, coaching, performance input, and development of audit competencies.
Auditors may include direct reports or matrixed audit team members.
Computer Skills:
Strong MS Office Skills – Outlook, Word, Excel, and PowerPoint. Experience with electronic quality management systems, document management, or audit management platforms preferred.
Other Qualifications:
Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality Assurance, or related discipline; advanced degree or relevant professional certification preferred, and 7+ years of computerized systems audit experience required OR Master’s degree and 5+ years of computerized systems audit experience preferred
Technical and Regulatory Knowledge: 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.
Travel: May require up to 25% travel, domestic or international.
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
