BeOne Medicines
Senior Manager, Global R&D Audits & Inspections Readiness
Remote (US) · Senior
Sponsorship not specifiedDetected 23 days ago
CI/CDDevOpsMachine LearningComplianceProduct ManagementAgileProcess ImprovementTest AutomationHIPAAFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationMentoringGxP
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odds of building a lasting career here
40Risky
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- 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.
- BeOne is a global biopharmaceutical company dedicated to the discovery and development of innovative drug therapies for the treatment of cancer.
Responsibilities
- May coordinate matrixed contributors, vendors, SMEs, product owners, engineering resources, and quality partners during readiness exercises, documentation cycles, audit preparation, and remediation activities.
- Coaches stakeholders on validation-by-design practices, inspection communication, documentation quality, evidence readiness, and compliance execution expectations.
- Agile Validation-by-Design Execution: Embedding GxP compliance tasks, evidence expectations, and validation artifacts into active sprint cycles and delivery workflows.
- Audit & Inspection Readiness Execution: Coordinating inspection preparation, technical storyboards, evidence retrieval, SME coaching, and front-room / back-room support for assigned audits or systems.
- Vendor & Externally Sourced System Compliance: Supporting assessment, periodic review, audit readiness, and compliance documentation for third-party platforms, SaaS providers, and external technology partners.
- Inspection Discipline: Maintains composure and precision during audit preparation and live inspection support, with strong attention to evidence quality and response accuracy.
- Proactive Continuous Quality Drive: Helps keep assigned systems, platforms, repositories, evidence, and readiness trackers in a state of ongoing inspection readiness.
Requirements
- Help define and apply GxP Definition of Done criteria so software completion includes required technical specifications, evidence, controls, and compliance checkpoints.
Nice to have
- Bachelor's degree in Computer Science, Information Technology, Bioengineering, Life Sciences, Quality, Regulatory, or a related field.
- An advanced degree is a plus.
Benefits
- 7+ years of experience in IT compliance, quality assurance, software engineering, systems validation, audit readiness, or related technology quality roles within the pharmaceutical, biotech, or medical device industry.
Company info
- At BeOne we believe that access to life-changing medicine sees no borders.
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This listing is sourced directly from BeOne Medicines's careers page and normalized into a canonical job model.