Senior Manager, GxP Computerized Systems Auditing

🔥 17 hours ago

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Develop and maintain the global computerized systems audit strategy and risk-based audit plan for GxP computerized systems • 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 auditor qualification and development requirements and improve audit methodology and effectiveness metrics • Plan and lead internal, supplier, vendor, contract organization, and partner audits involving computerized systems • Prepare audit plans, conduct interviews, review objective evidence, document observations, and issue risk-based audit reports • Lead audits of software vendors, cloud service providers, SaaS platforms, hosting providers, outsourced IT service providers, and other third parties • Evaluate vendor development, testing, validation, release, incident, change control, cybersecurity, and service management practices • Assess third-party compliance with regulations, contractual obligations, data integrity expectations, and company procedures • Evaluate corrective and preventive action plans for adequacy, effectiveness, and timely completion • Assess compliance with global GxP regulations, guidance, and industry standards • Evaluate governance, validation, and compliance controls for emerging technologies, including AI-enabled and advanced analytics systems • Evaluate cybersecurity controls, vulnerability management, business continuity, disaster recovery, and system resilience programs • Escalate systemic compliance risks, significant audit findings, and recurring control weaknesses • Support GxP audit programs and GxP Health Authority Inspections • Serve as process owner for the global computerized systems audit program • Develop and/or maintain SOPs and work instructions pertinent to the GxP audit program • Provide leadership, coaching, performance input, and competency development to auditors and subject matter experts • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality Assurance, or related discipline required; advanced degree or relevant professional certification preferred • 7+ years of computerized systems audit experience required with a bachelor’s degree, OR Master’s degree and 5+ years of computerized systems audit experience preferred • 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 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, and risk management principles • Strong understanding of applicable U.S., EU, China, and other global GMP/GDP requirements, as well as ICH expectations • Strong MS Office skills, including Outlook, Word, Excel, and PowerPoint • Experience with electronic quality management systems, document management, or audit management platforms preferred • 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% domestic or international travel

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Voluntary Employee Stock Purchase Plan • Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness