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BeOne

Global oncology therapeutics discovery, development, manufacturing

Director, GTS Enterprise Quality Technology

Enterprise ApplicationsConfirmed live in the last 24 hours
Full-timeHopewell, VA, USA$172.5k - $232.5k /yr

About the Job

Requirements

  • Experience leading enterprise QMS deployments, enhancements, application support, and project delivery for Quality Assurance systems in a pharmaceutical, biotechnology, or life sciences environment.
  • Hands-on experience with Veeva Quality applications, including implementation, configuration review, release support, testing coordination, issue resolution, and operational support.
  • Strong GTS or IT delivery experience, including service management, vendor management, release coordination, budget management, demand management, roadmap support, and cross-functional technology delivery.
  • Working knowledge of 21 CFR Part 11, data integrity expectations, GxP computer system validation, and Computer Software Assurance principles; emphasis is on applying approved procedures and maintaining validated systems rather than designing enterprise validation strategy.
  • Ability to work across GTS, Quality, site stakeholders, Procurement, Finance, and vendors to deliver reliable, compliant, and business-aligned technology solutions.
  • Bachelor’s degree in Engineering or Computer Science or a related technological field and at least 7 years of relevant experience building, configuring, and supporting Quality Assurance and/or Quality Control systems; alternatively, a master’s degree in one of those fields and at least 5 years of relevant experience.
  • Experience with Quality Assurance business processes including document control, training, deviations, CAPA, change control, complaints, audits, quality risk management, supplier quality, and inspection readiness.
  • Maintain strong communication, technical writing, stakeholder management, financial management, and presentation skills appropriate for cross-functional technology and Quality leadership forums.

Responsibilities

  • Lead GTS delivery, deployment, and operational support for enterprise QMS platforms and other Quality Assurance systems, with emphasis on Veeva Quality applications and related integrations.
  • Manage application operations across QMS and QA technology platforms, including incident and problem management, enhancement intake, configuration oversight, release coordination, service performance, operational metrics, user support, and lifecycle planning.
  • Translate Quality Assurance business requirements, QMS process needs, and compliance expectations into technology plans, Veeva configuration and enhancement approaches, delivery commitments, system changes, and support models with Quality stakeholders and GTS functions.
  • Manage delivery of Quality technology projects and initiatives, including scope, schedule, resources, budget, risks, dependencies, vendor performance, stakeholder communication, and operational readiness.
  • Provide hands-on leadership for Veeva Quality deployment activities, including requirements clarification, solution design input, configuration review, data and integration considerations, testing coordination, defect resolution, release readiness, and post-go-live stabilization.
  • Support deployment and enhancement of QA systems supporting document control, training, deviations, CAPA, change control, complaints, audits, quality risk management, supplier quality, inspection readiness, and related Quality processes.
  • Support creation, maintenance, and execution of the Quality Systems roadmap by consolidating demand with Quality and GTS leadership, assessing technical feasibility, estimating effort and cost, sequencing priorities, and converting roadmap items into executable delivery plans.
  • Manage department and project budgets, including forecasting, annual planning input, purchase requisitions, purchase orders, vendor spend oversight, accrual support, and routine financial reporting to leadership.
  • Partner with GTS architecture, infrastructure, cybersecurity, data, integration, service management, procurement, finance, and external vendors to deliver and support Quality technology solutions.
  • Ensure Quality systems remain validated and compliant by following approved SOPs, change control, release management, validation, CSA, data integrity, access management, and system lifecycle procedures.
  • Coordinate and support validation and CSA deliverables for system changes and projects, including planning input, documentation coordination, testing evidence review, deviation support, release readiness, and operational handover.
  • Maintain working knowledge of Quality business processes, GxP expectations, inspection readiness, and regulated system operations so technology decisions support the Quality organization.
  • Monitor technology service trends, compliance risks, project status, resource constraints, and vendor performance; escalate issues and recommend improvements to strengthen operational reliability and business value.
  • Communicate project delivery, operational performance, roadmap progress, budget status, risks, tradeoffs, and decisions required to Quality and GTS leadership.
  • Supervise approximately three direct reports supporting Quality technology operations, application support, and project delivery.
  • Provide coaching, performance management, workload prioritization, and professional development for team members.
  • Establish team priorities, operating rhythms, service expectations, project assignments, and accountability for technology operations, system lifecycle activities, and delivery commitments.
  • Promote collaboration across GTS functions, Quality business stakeholders, site teams, vendors, managed service partners, and shared service functions to resolve issues and deliver business outcomes.

Desired Qualifications

  • Experience with Quality platforms such as Validation Management System (ValGenesis), Inspection Management, AI tools used in pharma, laboratory, manufacturing, training, and/or other regulated Quality systems.

About the Company

BeOne

Global oncology therapeutics discovery, development, manufacturing

BeOne Medicines discovers, develops, and commercializes oncology therapies worldwide, focusing on hematologic cancers and solid tumors. Its products work by leveraging internal R&D and clinical development to bring therapies to market quickly, with Brukinsa serving as a leading backbone in the US and European markets. It differentiates itself through a large-scale global clinical network and cost-efficient development and manufacturing that support high margins and a focus on large-market cancer indications. Its goal is to expand access to high-impact, affordable cancer treatments across more than 45 countries while growing its pipeline into immunology and solid tumors.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Dongcheng District, China
Founded
2010

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