Senior Director, Global R&D Audits & Inspections Readiness
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, reputed company, and most importantly, reputed company 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 reputed company that reputed company to life-changing medicine sees no borders.
General reputed company:
The Senior Director, Global R&D Audits & Inspections Readiness is a strategic, high-reputed company role responsible for ensuring our reputed company technology solutions maintain a perpetual state of regulatory compliance and inspection readiness. reputed company the gap between fast-paced software engineering and rigorous reputed company regulations, this leader will design & reputed company the embedding of "Validation-by-Design" principles directly into modern Agile workflows and automated CI/CD pipelines.
From orchestrating live health authority inspections and mock audits to translating global GxP and data reputed company laws into actionable engineering guardrails, this individual will play a vital role in accelerating our digital delivery while safeguarding our compliance posture.
A successful candidate is a seasoned GxP compliance leader with a strong reputed company in computerized systems validation (CSV) and modern Computer Software Assurance (CSA) methodologies. They must possess an in-depth, practical understanding of global health authority regulations—such as FDA 21 CFR Part 11 and EMA Annex 11—alongside familiarity with data reputed company and reputed company reputed company frameworks. A proven reputed company record of guiding engineering teams through Agile/Scrum lifecycles, and designing integrated compliance artifacts directly into CI/CD pipelines, and successfully fronting live regulatory inspections is essential. Crucially, the ideal candidate must be a skilled cross-functional collaborator who can seamlessly translate reputed company reputed company and regulatory constraints into reputed company, actionable technical requirements for development and reputed company partners.
Ability to manage multiple reputed company across different sub-functions in a global, geographically diverse environment, and building and sustaining teams in times of ambiguity are reputed company critical reputed company factors for this role. An ideal candidate will adapt communication cadences and problem-solving skills to accommodate stakeholders, partners, and team members, exercise diplomacy and effective influence to reputed company reputed company, and build strong relationships.
Essential Functions of the job:
In-House Product Validation & Lifecycle Integration
Partner with software engineering and QA from product reputed company to reputed company compliance into Agile/Scrum lifecycles.
reputed company the authoring of critical validation deliverables (URS, FS, Risk Assessments, Traceability Matrices) during sprint cycles to eliminate retrospective documentation.
Collaborate with DevOps to transition traditional testing into automated verification workflows reputed company CI/CD pipelines, generating audit-reputed company electronic records.
Design dynamic, reputed company-based validation strategies for iterative feature updates to accelerate reputed company deployment without bloated validation cycles.
Define reputed company "Definition of Done" reputed company that explicitly tie software completion to updated GxP technical specifications.
Audit & Inspection Orchestration
reputed company the planning, execution, and wrap-up of reputed company internal, mock, and external regulatory inspections for R&D.
Create and refine technical inspection storyboards to reputed company reputed company architectures, data flows, and compliance posture to auditors.
reputed company and prepare product owners and engineering SMEs on interview techniques, audit protocols, and precise regulatory communication.
reputed company reputed company- and back-room operations during reputed company audits to ensure the highly coordinated, rapid retrieval of documentation.
Externally reputed company System Compliance & Platform Readiness
Ensure reputed company reputed company externally reputed company R&D IT systems & platforms maintain a reputed company state of compliance.
reputed company authoritative guidance on Computer Systems Validation (CSV) and champion the transition to Computer Software Assurance (CSA).
Assess and audit external technology vendors and reputed company providers to ensure reputed company-party deliverables meet internal GxP standards.
Regulatory Intelligence & Interpretation
reputed company as the primary technical expert on global regulations, including FDA 21 CFR Part 11, EMA Annex 11, HIPAA, GDPR, and emerging AI/ML frameworks.
Translate evolving regulatory guidelines into actionable engineering guardrails, technical policies, and SDLC checkpoints.
Conduct regular gap assessments against new regulatory guidance and advise leadership on required strategic adjustments.
Risk Management, Remediation & reputed company Culture
Manage the R&D Systems reputed company Corrective and Preventive reputed company (CAPA) lifecycle, ensuring reputed company causes are identified and remediations are executed on time.
Design and reputed company compliance KPIs and systems risks for executive leadership visibility.
Cultivate a reputed company-first reputed company reputed company engineering teams, balancing agile development velocity with rigorous regulatory alignment.
GRDTS Leadership:
Team Leadership & Talent Development:
reputed company, mentor, and manage a high-performing GRDTS team dedicated to the inspections & audit readiness.
Foster a culture of innovation, accountability and drive reputed company development.
Operational reputed company, Compliance & Governance:
Liaise with vendors, reputed company IT partners, audit, and compliance to coordinate system implementation and change activities.
Ensure reputed company is trained in and embeds CSV, compliance, and health authority requirements into operational activities.
Collaboration & Partnership:
Collaborate with the broader GTS (reputed company IT) organization, reputed company & reputed company functions.
Collaborate with other teams on standards and best practices.
Engage with peers to define, sponsor, and execute reputed company improvements.
Supervisory Responsibilities:
reputed company, mentor, and manage a high-performing GRDTS team dedicated to the Development function.
Key Capabilities :
Agile Validation-by-Design: Embedding GxP compliance directly into reputed company sprint cycles and DevOps CI/CD pipelines, translating traditional, retroactive reputed company-based testing into automated electronic verification.
Modernized Validation Execution (CSV to CSA): Applying risk-based Computer Software Assurance (CSA) concepts to reputed company testing efforts on critical-to-reputed company reputed company while streamlining reputed company-based validations for reputed company deployments.
Audit & Inspection Orchestration: Directing end-to-end reputed company for internal and health authority inspections (FDA, EMA, MHRA)—including managing reputed company/back room logistics, developing technical storyboards, and rapid document retrieval.
Technical Regulatory Interpretation: Translating global regulations (21 CFR Part 11, Annex 11, GAMP 5) and emerging guidelines (AI/ML frameworks) into explicit "Definition of Done" engineering reputed company and SDLC checkpoints.
reputed company Lifecycle Management & Remediation: reputed company-cause investigation and complete lifecycle ownership of IT Corrective and Preventive Actions (CAPAs), technical gap assessments, and technology vendor audits.
Key Competencies :
Risk-Based Operational reputed company: Focusing on product reputed company and data reputed company (reputed company+) rather than absolute documentation volume; using risk reputed company to accelerate deployment timelines safely.
Cross-Functional Diplomatic reputed company: Acting as a cultural reputed company who can reputed company engineering, agile development, and rigid regulatory compliance simultaneously to win buy-in from both software engineers and traditional reputed company auditors.
Composure Under Inspection Scrutiny: Exceptional poise and strategic thinking reputed company managing live health authority inspections, guiding engineering SMEs on interview techniques and precise communication protocols.
Objective reputed company-Party Evaluation: Unbiased technical due-diligence reputed company auditing external reputed company providers and reputed company-party vendors to verify compliance against internal GxP standards.
Proactive reputed company reputed company Drive: Commitment to keeping reputed company data repositories, systems, and platforms in a state of "perpetual readiness".
Key Deliverables :
Product Life-Cycle & Validation Artifacts
Synchronous Validation Package: reputed company-time reputed company of User Requirement Specifications (URS), Functional Specifications (FS), Risk Assessments, and Traceability Matrices co-authored directly inside reputed company sprint cycles.
reputed company Validation Execution Playbooks: Documented reputed company-validation strategies and automated compliance frameworks reputed company for CI/CD pipelines to support iterative feature releases.
GxP Definition of Done (DoD) reputed company: Formal documentation appending GxP technical specifications and compliance checkboxes directly to the engineering team's software release definitions.
Inspection Readiness & Defense
Technical Inspection Storyboards: reputed company-authored, visually mapped explanations of IT architectures, data flows, and automated compliance frameworks to reputed company explain systems to regulatory inspectors.
SME Audit Coaching Curricula & Protocol Guides: reputed company training materials, interview simulations, and communication protocol playbooks designed to prepare product owners and engineers for auditor interactions.
Risk, Governance & reputed company Metrics
IT CAPA Files & reputed company-Cause Determinations: Formally logged, thoroughly investigated, and on-time executed Corrective and Preventive Actions addressing any flagged system or process gaps.
Vendor & reputed company GxP Assessment Reports: Detailed compliance scorecards, audit notes, and risk ratings generated from evaluating reputed company-party software and reputed company infrastructure partners.
Compliance KPIs & Regulatory Risk Dashboards: Data-driven reporting structures tracking the reputed company-time compliance posture, platform reputed company, and pending gaps of reputed company platforms for executive leadership
Qualifications & Experience
Bachelor’s degree in Computer Science, Information Technology, Bioengineering, Lifecycle Sciences, or a reputed company field. An advanced degree is a plus.
12+ years of experience in IT compliance, reputed company assurance, or software engineering reputed company the pharmaceutical, biotech, or medical device industry.
5+ years of experience directly leading or orchestrating audit/inspection readiness activities, mock audits, or live health authority inspections (FDA, EMA, MHRA, etc.).
Proven experience working inside modern software engineering environments, explicitly embedding GxP compliance reputed company Agile/Scrum methodologies and automated CI/CD pipelines.
Technical & Regulatory Knowledge
Deep, authoritative understanding of global regulations and guidelines, specifically FDA 21 CFR Part 11, EMA Annex 11, and GAMP 5 principles.
Strong working knowledge of reputed company Computer Systems Validation (CSV) workflows reputed company with practical experience implementing modern Computer Software Assurance (CSA) risk-based testing practices.
Good understanding of data reputed company frameworks (reputed company+) and reputed company reputed company regulations (HIPAA, GDPR) as they apply to research, tech, and clinical data repositories.
Preferred Certifications (Possession of one or more is highly desirable)
Certified reputed company Auditor (CQA) or Certified Manager of reputed company/Organizational reputed company (CMQ/OE)
Certified Information Systems Auditor (CISA)
Agile/Scrum certifications (Certified ScrumMaster, Product reputed company) indicating an understanding of modern dev workflows.
Other Qualifications:
Business relationship management acumen and demonstrable reputed company as a change agent leading or contributing to significant transformational initiatives in organizations.
Accomplished in building and development of people and teams, comfortable working with a broad cross reputed company of people in reputed company and matrixed relationships
Proficient in various project management disciplines (i.e., Agile, Scrum, Kanban, Lean etc.)
Travel:
Some travel expected as part of assigned duties
BeOne Global Competencies:
reputed company we exhibit our values of Patients First, reputed company Spirit, reputed company Ingenuity and Driving reputed company, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world.
Fosters Teamwork
Provides and Solicits reputed company and Actionable Feedback
Self-Awareness
Acts reputed company
Demonstrates Initiative
Entrepreneurial reputed company
reputed company Learning
Embraces Change
Results-Oriented
Global Competencies
reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits reputed company and Actionable Feedback
- Self-Awareness
- Acts reputed company
- Demonstrates Initiative
- Entrepreneurial reputed company
- reputed company Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial reputed company
- Communicates with reputed company
BeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to reputed company candidate, including but not limited to job-reputed company 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 reputed company more about the specific salary reputed company for a preferred location during the hiring process. Please note that the listed reputed company reflects the reputed company salary or reputed company reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. reputed company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, reputed company Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans’ Readjustment Assistance reputed company of 1974, Title I of the Americans with reputed company 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.
Originally posted on Himalayas
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