Senior Manager, Global R&D Audits – Inspections Readiness

🕒 il y a 5 jours

🇺🇸 États-Unis – Télétravail

💵 $147 800 - $192 800 / an

⏰ Temps Plein

🟠 Senior

👔 Manager

👻 Score fantôme 0%

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BeOne Medicines

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 2010

🧬 Biotechnologie

🏥 Santé

💊 Pharmaceutique

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines est une entreprise mondiale d’oncologie dont le siège est en Suisse. Elle découvre et développe des traitements innovants, plus abordables et plus accessibles aux patients atteints de cancer dans le monde entier. Avec un portefeuille couvrant l’hématologie et les tumeurs solides, BeOne accélère le développement de son pipeline diversifié de nouvelles thérapies grâce à ses capacités internes et à ses collaborations. Forte d’une équipe mondiale en croissance de plus de 11 000 collaborateurs présents sur six continents, l’entreprise s’engage à améliorer radicalement l’accès aux médicaments pour un bien plus grand nombre de patients qui en ont besoin.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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