Senior Manager, Global R&D Audits – Inspections Readiness

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $147.8k - $192.8k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 1%

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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

• Execute validation-by-design activities with software engineering, product owners, and QA within Agile / Scrum delivery • Coordinate URS, FS, risk assessments, test evidence, traceability matrices, and release readiness documentation • Align automated testing, CI/CD evidence, electronic records, and release controls with audit-ready verification expectations • Apply delta-based validation to iterative feature updates • Define and apply GxP Definition of Done criteria • Lead workstreams for internal audits, mock inspections, inspection readiness exercises, and external health authority inspection preparation • Prepare technical inspection storyboards, system narratives, architecture summaries, data flow explanations, evidence packages, and document retrieval plans • Coach product owners, engineering SMEs, vendors, and support teams on audit protocols and interview preparation • Support front-room and back-room audit or inspection operations • Oversee externally sourced R&D IT systems, platforms, vendors, and SaaS providers for compliance and inspection readiness • Support vendor qualification, periodic reviews, compliance assessments, audit preparation, and third-party deliverable reviews • Coordinate CSV / CSA execution for vendor-hosted or externally developed systems • Translate regulatory and quality expectations into engineering and system lifecycle actions • Support regulatory gap assessments and recommend remediation or process improvements • Partner with Quality, Compliance, Security, and Enterprise IT on policies, SDLC checkpoints, and system controls • Manage CAPA, audit finding, remediation, and gap closure activities • Maintain compliance KPIs, inspection readiness trackers, risk logs, platform readiness views, and issue updates • Provide status, risk, dependency, and decision updates to the Senior Director • Coordinate matrixed contributors, vendors, SMEs, product owners, engineering resources, and quality partners • Coach stakeholders on validation-by-design, inspection communication, documentation quality, evidence readiness, and compliance execution

🎯 Requirements

• Bachelor’s degree in Computer Science, Information Technology, Bioengineering, Life Sciences, Quality, Regulatory, or a related field • 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 • 3+ years of experience supporting audit / inspection readiness activities, mock audits, regulatory inspections, vendor audits, validation programs, CAPA execution, or compliance remediation • Practical experience embedding GxP compliance into Agile / Scrum delivery, system lifecycle practices, validation documentation, test evidence management, and/or DevOps / CI/CD workflows • Strong working knowledge of FDA 21 CFR Part 11, EMA Annex 11, GAMP 5 principles, CSV, CSA, ALCOA+, HIPAA, and GDPR • Ability to apply risk-based testing, delta validation, change impact assessment, requirements traceability, evidence review, vendor compliance assessment, and inspection readiness practices • Familiarity with modern software delivery, cloud / SaaS platforms, externally sourced systems, AI/ML technology considerations, and regulated R&D data environments • Business relationship management acumen and ability to influence cross-functional stakeholders • Strong documentation, communication, facilitation, issue management, and follow-through skills • Ability to work with direct, matrixed, vendor, and inspection support relationships • Proficiency in Agile, Scrum, Kanban, Lean, release readiness, audit preparation, and remediation tracking

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Voluntary participation in the Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid Time Off • Wellness program • Some travel expected as part of assigned duties • Reasonable accommodation for applicants protected by applicable laws