BeOne Medicines

Supply Chain

• Lead Clinical Supply teams (Supply Chain Leads and other execution-oriented roles such as Label Development, CMO Management, etc.) as a part of an overall global supply chain management role
• Provide managerial support to several employees with the overall responsibility of leading, training, and mentoring for effective performance
• Build strategic relationships with internal stakeholders and ensure alignment
• Oversee the creation of Clinical Supply Plans and Demand forecasts, packaging and distribution
• Oversee management of cGMP inventory throughout the supply chain and ensure drug accountability
• Represents Clinical Supply Chain organization on Development Review Committee (DRC) and Development Core Team (DCT) as required
• Act as point of escalation for Clinical Study Teams
• Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
• Prepare and manage the Clinical Supply Chain functional budget
• Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure
• Lead/Sponsor projects and process improvements related to clinical drug supply
• Lead and assist in the creation of Standard Operating Procedures and Policies
• Other activities as required

Director, Clinical Supply Chain

Director

• Lead global HEOR/RWE strategy and evidence generation activities for the BTK degrader asset across product lifecycle, ensuring alignment with cross-functional objectives
• Develop and execute integrated value evidence generation plan, including disease burden, treatment patterns, comparative effectiveness, indirect comparisons, economic modeling, and patient-centered outcomes to demonstrate clinical and economic value
• Design and execute real-world evidence and comparative effectiveness studies using various real-world data sources including claims and electronic health records to support differentiation
• Collaborate with cross-functional partners on JCA/HTA submissions and lead key HEOR deliverables timely including indirect comparisons and economic modeling
• Lead development of Global Value Dossiers and US AMCP dossier to support reimbursement submissions and value communication
• Drive scientific dissemination of HEOR/RWE evidence through abstracts, manuscripts, and congress presentations and omnichannel distributions

Director, Global Health Economic & Outcomes Research – HEOR/RWE Lead

Business Operations

• Assist in identifying relevant data sets
• Collect and categorize all data inputs
• Basic statistical analysis
• Data display and chart design
• Identify missing components from the using the new hire vantage point
• Minor administrative tasks as assigned
• Flexibility on work schedule times since this is a Global Project

Global Quality Strategy and Business Operations Intern

Manager

• Reporting to the SVP Head of Europe, the General Manager (GM) UK&I plays a pivotal role in defining and executing the country strategy across competitive markets.
• The incumbent will be responsible to represent the company with high level, outside stakeholders, like payers and other institutional stakeholders of the country.
• Responsible for achieving revenue and profit targets as well as the growth expectations.
• Accountable for the design and implementation of a strategic business plan in the country.
• Expected to lead a management team to help implement the strategy, in alignment with the European/Global strategy and approved by the SVP Head of Europe.
• Provide exceptional leadership to a culturally diverse team; fostering an environment to drive high performance, engagement, accountability, empowerment, and behaviors consistent with the Company’s values and culture.
• Foster a leadership culture that attracts, develops and retains high-caliber candidates.
• Create effective internal communication and foster teamwork.
• Develop a highly committed leadership team, providing sound leadership and coaching.
• Build the strategic direction and vision for the Country and aggressively drive growth across hematology.
• Set ambitious sales objectives for in-market products and ensure exceptional execution of launch plans for new products.
• Drive sustainable financial performance through strategic financial planning, resources management, operational excellence, and data-driven performance oversight.
• Establish strong relationships with major stakeholders like regulatory bodies, payers, politicians, industry associations, and Key Opinion Leaders to support organizational goals.
• Ensure compliance with The Company's Standards of conduct and all applicable local laws and regulations.

General Manager

Artificial Intelligence

• Lead the design, scaling, and adoption of AI-driven solutions across Commercial and Medical Affairs functions
• Act as a senior thought partner to Commercial and Medical functional leaders
• Drive adoption of AI-driven tools by embedding them into workflows, processes, and decision forums
• Create a strategic roadmap for high value, high impact AI capabilities
• Translate enterprise AI strategy into prioritized roadmaps
• Oversee the evaluation, refinement, and performance monitoring of AI models
• Lead the design, development, and scaling of AI-driven platforms and solutions
• Own and manage a portfolio of AI and innovation initiatives
• Establish clear success metrics and governance mechanisms to track
• Lead and mentor multiple teams of data scientists, AI engineers, and other technology functions
• Stay abreast of emerging AI methodologies, tools, and platforms
• Collaborate with external partners, vendors, and internal centers of excellence as needed

Senior Director, Innovation and Commercial AI Enablement

Executive Assistant

• Provide support to the Chief Technology Officer and other team members as needed.
• Schedule and manage appointments, meetings, and events to maximize the leader's time and efficiency.
• Coordinate travel logistics, including flights, accommodations, transportation, and itineraries.
• Oversee and manage the senior leader's expenses, including preparing monthly expense reports, tracking reimbursements, and ensuring compliance with company policies.
• Understand business priorities and proactively look for ways to streamline the support matrix.
• Build and maintain key external relationships.
• Build and maintain internal cross-functional relationships, including the Office of the CEO and Board members.
• Assist with planning and executing special projects, ensuring deadlines and objectives are met.
• Partner with the Executive Assistants across the enterprise to share best practices.
• Schedule and coordinate candidate phone, video and in-office interviews.
• Process purchase requisitions and contract.
• Provide assistance as needed for assigned department.
• Handle sensitive information with discretion and maintain confidentiality at all times.

Executive Assistant, Global Technology Solutions

Learning and Development

• Lead the Full Instructional Design Lifecycle
• Conduct needs analysis, design learning objectives, develop instructional content, and evaluate effectiveness using measurable performance outcomes
• Ensure learning solutions are engaging, compliant, and aligned with both global quality standards and business priorities
• Develop engaging and scalable learning solutions for global quality initiatives, including GxP compliance, deviation management, CAPA, document control, change management, and inspection readiness
• Create high-quality learning experiences, including instructor-led training (ILT), virtual ILT (vILT), eLearning, hands-on skill labs, simulations, and performance support tools
• Apply adult learning theory, cognitive load management, and instructional design best practices to create effective learning interventions
• Collaborate with subject matter experts (SMEs), global quality leaders, and regional training coordinators

Senior Manager, Instructional Designer – GXP Training

Operations

• Support the implementation and maintenance of efficient, effective, and compliant QMS processes that align with BeOne’s quality and business objectives.
• Collaborate with the QMS Process Oversight and Performance Management team and BPOs to define, track, and analyze key performance indicators (KPIs), identify trends, and recommend actions to enhance process performance.
• Support Quality Council, Management Review, and other governance meetings by ensuring KPIs, clear summaries of process performance, and effective communication of risks, trends, and required actions.
• Contribute to digital transformation initiatives by supporting the implementation of tools, automation, and analytics that modernize QMS processes and improve data visibility and system performance.
• Collaborate with process owners and governance teams to review and enhance QMS policies and enterprise SOPs, ensuring clarity, consistency, and compliance with regulatory expectations.
• Partner with functional teams to improve the technical accuracy and clarity of documentation within Deviations, Complaints, Change Controls, and other QMS records, providing guidance on root cause analysis and compliant documentation practices.
• Lead or contribute to cross-functional improvement projects to streamline QMS workflows, enhance user experience, and improve right-first-time execution of quality records.
• Support internal and external audit and inspection readiness by ensuring QMS documentation and records are complete, current, and easily accessible.
• Work cross-functionally with Quality, Technical Operations, Regulatory, and other business partners to promote alignment and continuous improvement across QMS processes.

Associate Director, QMS Process Improvement, Analytics

Business Analyst

• Serve as the business System Owner for assigned Quality GxP digital systems (e.g., eQMS, QualityDocs, etc)
• Lead and manage full lifecycle of system implementations and enhancements
• Gather and translate complex business needs into functional and technical requirements
• Drive process mapping, continuous improvement, and digital transformation initiatives across Quality
• Collaborate with cross-functional teams including QA, IT, Regulatory, Clinical, and external vendors to align systems with business strategy
• Develop and maintain strong relationships with business process owners and ensure systems meet evolving needs
• Plan and lead UAT, training, and change management activities for new system features or implementations
• Manage project scope, timeline, resources, budgets, and risks, escalating issues as needed
• Ensure ongoing system compliance with applicable GxP, FDA, EMA, and ISO standards
• Oversee the governance, configuration, and administration of digital quality tools such as Veeva QMS

Senior Manager, Digital Quality Management Systems, Business Analyst

• Develop and execute clinical pharmacology and pharmacometrics strategies to mitigate risks and support development of small molecule and/or biologics drug candidates
• Develop clinical pharmacology study designs and collaborate with CROs and Clinical Operations to write study protocols, amendments, and reports
• Conduct hands-on clinical PK and pharmacometric data analysis
• Analyze, interpret, summarize, and present data to internal project teams, senior management, and to global health authorities
• Present data and interpretations to health authorities to enable optimal clinical development and registration of novel drugs
• Author, review, and finalize relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions

Director, Clinical Pharmacology – Pharmacometrics

Risk

• Develop, maintain and implement assigned GxP/Quality incident management processes that align with organizational goals and latest regulatory requirements on global level.
• Manage and oversee the intake, triage, investigation, documentation, and resolution of GxP and quality-related issues and incidents in an end-to-end process.
• Partner with manufacturing, quality assurance, quality control, regulatory affairs, clinical operations, development, patient safety and other stakeholders to ensure timely and thorough management of GxP and quality incidents.
• Drive and support comprehensive root cause investigations.
• Ensure that the Escalation and Notification to Management related activities and documentation meet the relevant regulatory agency and other relevant requirements for the industry (FDA, EMA, any local regulations, ISO, WHO); prepare for and support inspections and audits.
• Develop and deliver training on incident management procedures, share lessons learned from managed GxP/Quality incidents and promote a culture of quality and accountability across the organization.
• Ensure meeting of key performance indicators (KPIs), track incident trends, and provide regular reports.

Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge Management

• Owns the process which captures and examines BeOne’s product knowledge throughout the commercial lifecycle
• Maintains oversight on process capability through data trending and statistical analysis of critical variables
• Ensures process(es) are robust, in continued state of validation and continuously improving
• Ensures reliability and access to product information, process knowledge across functions via QMS systems
• Provides second line technical/scientific process support
• Supports cross-functional collaboration, drives process improvements, and enhances the organization's approach to quality governance using evidence backed decision making
• Collaborates across functions and sites to drive continuous improvement, ensure regulatory compliance, and build a robust knowledge-sharing and risk management culture
• Contributes to product quality performance monitoring, identifying trends and driving improvements
• Collaborates with R&D, manufacturing (CMC) and regulatory teams to ensure quality considerations are embedded in new product development and lifecycle management
• Manages change tracking and implementation for actions related to Regulatory CMC commitments
• Leads or participates in cross-functional teams to improve quality systems and address systemic challenges
• Represents the Quality Organization at platform level through participation in molecule level governance meetings and forums
• Supports regulatory inspections and audits, ensuring alignment with global quality standards and best practices
• Actively mentors new and existing team members to develop core Product Quality skills and leadership skills
• Performs other related responsibilities as assigned.

Associate Director, BPO Global APQR, Product Data Quality

• Develop and implement effective communication strategies to inform and engage users before, during, and after the adoption of new digital quality tools and processes.
• Collaborate with key stakeholders to understand their needs, expectations, and concerns regarding digital adoption and changes.
• Build and maintain strong relationships with various departments to facilitate open communication and support for initiatives.
• Create informative materials such as newsletters, presentations, and other communication assets.
• Design and deliver comprehensive training programs tailored to different user groups based on their roles and levels of digital proficiency.
• Prepare user guides, FAQs, and other relevant documentation to support ongoing learning and development.
• Monitor the progress of digital tool adoption and identify potential barriers to usage.
• Conduct surveys and feedback sessions to assess user satisfaction and engagement.
• Identify and mitigate risks associated with the change process.
• Develop risk assessment plans and implement risk mitigation strategies.
• Create dashboards, KPIs, and metrics to evaluate adoption effectiveness and overall success of digital initiatives.
• Provide regular reports to management highlighting progress, challenges, and recommendations for improvement.
• Maintain thorough documentation of change management processes, methodologies, and lessons learned to ensure consistency and efficiency in future initiatives.
• Gather and analyze feedback from users to identify opportunities for continuous improvement in systems training and adoption strategies.
• Stay current with industry best practices and emerging trends in digital adoption and change management.
• Support the optimization of digital adoption tools like WalkMe, ensuring they are effectively utilized to enhance user experience.
• Create engaging content for digital adoption tools, including step-by-step guides, in-app tutorials, and interactive training modules.
• Serve as the Business Process Owner for AI capabilities within Global Quality, driving cross‑functional alignment on requirements, governance, and standards for AI‑enabled workflows.
• Define, maintain, and continuously improve AI‑enabled business processes, including governance models, RACI, decision workflows, and process controls related to AI use in Quality Systems.
• Lead the evaluation, prioritization, and intake of AI opportunities within Global Quality, maintaining an AI capability roadmap that supports efficiency, automation, and predictive insights.
• Represent Global Quality in cross‑functional AI governance bodies, ensuring Quality requirements are embedded in enterprise AI frameworks and decision‑making.

Associate Director, Digital Quality Management Systems, Change Management, Digital Adoption

• Perform EU QP certification for commercial products under BeOne responsibility for the products of BeOne Medicines I GmbH, Dutch Branch.
• Ensure compliance with legal requirements and oversee QMS of QP operational responsibilities.
• Maintain Manufacturing and Import Authorization and ensure GMP knowledge within the team.
• Participate in audits and inspections, ensuring accuracy and quality of records.
• Support regulatory inspections and manage authorized activities.
• Authorize recalls and cooperate with necessary departments for communication with authorities.

Senior Manager, EU Qualified Person – Commercial Products

• Transform global data capabilities by institutionalizing data as the "default input" for critical business decisions.
• Orchestrate the integration of process data and business data, leveraging AI to drive efficiency.
• Build a data framework to evaluate the health, progress, and ROI of business assets.
• Provide the leadership team with objective data for critical resource allocation and stage-gate decisions.
• Conduct deep dives into core operational flows to identify bottlenecks and cost inefficiencies.
• Act as the bridge between technical data teams and business stakeholders.
• Establish a robust monitoring system for critical business metrics and implement automated anomaly detection.
• Ensure that every data alert triggers a defined response mechanism.
• Spearhead the cleanup of historical data issues and define a "Single Source of Truth" across the organization.
• Drive the adoption of AI/ML to automate manual analysis and reporting.