Senior Manager, Global R&D Audits & Inspections Readiness

BeiGene

12d•$147,800 - $192,800

About The Position

The Senior Manager, Global R&D Audits & Inspections Readiness is an execution-focused role responsible for helping maintain a continuous state of regulatory compliance and inspection readiness for R&D technology solutions. Reporting to the Senior Director, this role translates audit readiness strategy, validation-by-design principles, regulatory expectations, and quality standards into practical day-to-day execution across assigned systems, products, vendors, and readiness activities. The role partners closely with software engineering, product owners, Quality, Compliance, Enterprise IT, Security, vendors, and R&D stakeholders to embed GxP compliance, computerized systems validation (CSV), Computer Software Assurance (CSA), and data integrity expectations into Agile / Scrum delivery, automated testing, CI/CD practices, system lifecycle documentation, and operational support activities. Because there will be three Senior Manager roles within this capability area, each Senior Manager may be assigned a combination of execution focus areas to ensure full coverage across the capability. Potential focus-area combinations include product lifecycle validation and agile delivery readiness; audit / inspection coordination and SME preparation; externally sourced system, vendor, and SaaS compliance; regulatory intelligence translation; CAPA / remediation tracking; and compliance metrics / readiness dashboards. A successful candidate brings practical GxP compliance, CSV / CSA, audit readiness, and technology delivery experience, with the ability to coordinate detailed execution across multiple stakeholders. The role requires strong documentation discipline, risk-based thinking, inspection composure, and the ability to translate regulatory and quality expectations into clear technical actions for engineering and product teams.

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, data integrity expectations such as ALCOA+, and relevant privacy / security considerations such as 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 in quality, technology, security, vendor, and R&D environments.
Strong documentation, communication, facilitation, issue management, and follow-through skills, with the ability to translate complex regulatory expectations into practical execution tasks.
Comfortable working with a broad cross-section of people in direct, matrixed, vendor, and inspection support relationships.
Proficient in project and delivery practices such as Agile, Scrum, Kanban, Lean, release readiness, audit preparation, and remediation tracking.

Nice To Haves

An advanced degree is a plus.
Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Information Systems Auditor (CISA), or equivalent quality / audit certification.
Agile / Scrum certification such as Certified ScrumMaster or Product Owner, indicating understanding of modern software delivery workflows.

Responsibilities

Execute assigned validation-by-design activities with software engineering, product owners, and QA to embed GxP expectations into Agile / Scrum delivery practices.
Coordinate the creation, review, and maintenance of validation deliverables such as User Requirement Specifications (URS), Functional Specifications (FS), risk assessments, test evidence, traceability matrices, and release readiness documentation during active delivery cycles.
Support DevOps and engineering teams in aligning automated testing, CI/CD evidence, electronic records, and release controls with audit-ready verification expectations.
Apply delta-based validation approaches for iterative feature updates, ensuring changes are evaluated, documented, tested, and released in line with risk-based standards.
Help define and apply GxP Definition of Done criteria so software completion includes required technical specifications, evidence, controls, and compliance checkpoints.
Lead assigned 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 for assigned systems or topics.
Coach product owners, engineering SMEs, vendors, and support teams on audit protocols, interview preparation, response discipline, and precise regulatory communication.
Support front-room and back-room operations during active audits or inspections, coordinating rapid evidence retrieval, response tracking, SME availability, and follow-up documentation.
Oversee assigned externally sourced R&D IT systems, platforms, vendors, or SaaS providers to help maintain continuous compliance and inspection readiness.
Support vendor qualification, periodic review, compliance assessment, audit preparation, and review of third-party deliverables against internal GxP expectations.
Coordinate CSV / CSA execution for vendor-hosted or externally developed systems, ensuring requirements, risk rationale, test evidence, traceability, and operational controls are complete and current.
Translate assigned regulatory and quality expectations, including FDA 21 CFR Part 11, EMA Annex 11, GAMP 5, ALCOA+, HIPAA, GDPR, and emerging AI/ML guidance, into practical engineering and system lifecycle actions.
Support gap assessments against new or changing regulatory guidance and document recommended remediation or process improvement actions for leadership review.
Partner with Quality, Compliance, Security, and Enterprise IT to align technical policies, SDLC checkpoints, and system controls with regulatory expectations.
Manage assigned R&D systems-related CAPA, audit finding, remediation, or gap closure activities, ensuring actions are tracked, owners are aligned, and evidence is completed on time.
Maintain compliance KPIs, inspection readiness trackers, risk logs, platform readiness views, and issue status updates for assigned systems or focus areas.
Promote a quality-first mindset within engineering and product teams by balancing agile delivery speed with data integrity, validation, security, and regulatory requirements.
Apply standard ways of working for validation documentation, inspection readiness evidence, audit response tracking, CAPA execution, and system compliance reporting.
Ensure assigned activities embed CSV, CSA, compliance, data integrity, privacy, security, and health authority expectations into day-to-day operational work.
Collaborate with Enterprise IT, Quality, Security, vendors, software engineering, product owners, and R&D stakeholders to complete assigned audit readiness and compliance execution activities.
Provide concise status, risk, dependency, and decision updates to the Senior Director to support prioritization, inspection readiness, and leadership visibility.
Provides day-to-day execution leadership for assigned audit readiness, validation, vendor compliance, CAPA, readiness metrics, and inspection support workstreams.
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.