Senior Manager, Global R&D Audits & Inspections Readiness

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. At BeOne we believe that access to life-changing medicine sees no borders.

General Description:

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.

Essential Functions of the job:In-House Product Validation & Lifecycle Integration

• 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.

Audit & Inspection Orchestration

• 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.

Externally Sourced System Compliance & Platform Readiness

• 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.

Regulatory Intelligence & Interpretation

• 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.

Risk Management, Remediation & Quality Culture

• 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.

GRDTS Leadership:Operational Excellence, Compliance & Governance:

• 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.

Collaboration & Partnership:

• 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.

Supervisory Responsibilities:

• No direct line-management responsibilities are required. 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.

Assigned Focus Area Model for Senior Manager Roles :

• Senior Manager roles are expected to cover multiple execution focus areas rather than operate as isolated single-domain roles.

• Possible focus-area coverage may include: product lifecycle validation and CSA delivery; audit / inspection orchestration and SME readiness; externally sourced system / vendor compliance; regulatory intelligence and policy translation; CAPA / remediation execution; compliance KPIs and readiness dashboards.

• Specific focus areas may be assigned or adjusted based on R&D portfolio priorities, inspection calendar needs, system risk, vendor landscape, and capacity.

Key Capabilities :

• Agile Validation-by-Design Execution: Embedding GxP compliance tasks, evidence expectations, and validation artifacts into active sprint cycles and delivery workflows.

• Modernized Validation Execution (CSV to CSA): Applying risk-based CSA concepts to assigned systems, focusing testing and documentation on critical-to-quality elements while supporting accelerated, compliant releases.

• Audit & Inspection Readiness Execution: Coordinating inspection preparation, technical storyboards, evidence retrieval, SME coaching, and front-room / back-room support for assigned audits or systems.

• Technical Regulatory Translation: Converting regulatory expectations and quality requirements into practical SDLC checkpoints, system controls, definition-of-done criteria, and engineering actions.

• Quality Lifecycle Management & Remediation: Tracking CAPA, gap assessments, vendor findings, remediation actions, root-cause inputs, and readiness evidence through closure.

• Vendor & Externally Sourced System Compliance: Supporting assessment, periodic review, audit readiness, and compliance documentation for third-party platforms, SaaS providers, and external technology partners.

Key Competencies :

• Risk-Based Operational Mindset: Focuses effort on patient safety, product quality, data integrity, and critical system controls rather than documentation volume alone.

• Cross-Functional Collaboration: Works effectively across engineering, product, Quality, Compliance, Enterprise IT, Security, vendors, and R&D stakeholders.

• Inspection Discipline: Maintains composure and precision during audit preparation and live inspection support, with strong attention to evidence quality and response accuracy.

• Objective Third-Party Evaluation: Reviews vendor and SaaS documentation, system evidence, and compliance commitments against internal GxP standards and risk expectations.

• Proactive Continuous Quality Drive: Helps keep assigned systems, platforms, repositories, evidence, and readiness trackers in a state of ongoing inspection readiness.

Key Deliverables :Product Life-Cycle & Validation Artifacts

• Validation Documentation Packages: URS, FS, risk assessments, testing evidence, traceability matrices, release readiness evidence, and lifecycle documentation for assigned systems or releases.

• Delta Validation & CSA Execution Materials: Risk-based validation plans, change impact assessments, automated evidence expectations, CI/CD control evidence, and CSA rationale for iterative releases.

• GxP Definition of Done Inputs: Practical engineering completion criteria, compliance checkpoints, and evidence expectations for assigned products or delivery teams.

Inspection Readiness & Defense

• Technical Inspection Storyboards: System narratives, architecture overviews, data flow summaries, control explanations, and evidence maps for assigned systems or topics.

• SME Audit Preparation Materials: Training notes, mock interview scripts, response guidance, document retrieval checklists, and communication protocols for product owners and engineering SMEs.

Risk, Governance & Quality Metrics

• CAPA / Finding Execution Files: Root-cause inputs, action plans, evidence packages, status trackers, and closure documentation for assigned system or process gaps.

• Vendor & SaaS GxP Assessment Inputs: Compliance assessment notes, evidence reviews, gap findings, risk ratings, and readiness recommendations for third-party systems.

• Compliance KPI & Readiness Reporting: Assigned readiness metrics, dashboard inputs, risk registers, gap trackers, and leadership status updates.

Qualifications & Experience

• Bachelor’s degree in Computer Science, Information Technology, Bioengineering, Life Sciences, Quality, Regulatory, or a related field. An advanced degree is a plus.

• 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.

Technical & Regulatory Knowledge

• 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.

Preferred Certifications (Possession of one or more is desirable)

• 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.

Other Qualifications:

• 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.

Travel:

• Some travel expected as part of assigned duties

BeOne Global Competencies:

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $147,800.00 - $192,800.00 annuallyBeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.