BeiGene · 6 hours ago
Senior Manager, Digital Quality Management Systems, Business Analyst
United States
Full-time
Remote
Senior Level
$133K/yr - $178K/yr
7+ years expBeiGene is a company dedicated to fighting cancer, seeking experienced professionals who are highly motivated and collaborative. The Senior Manager, Digital Quality Management Systems Business Analyst will support and execute the strategy, implementation, and lifecycle management of digital Quality Systems while ensuring alignment between technology solutions and business requirements.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
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
Prepare and deliver high-quality project updates, stakeholder communications, and system documentation
Oversee the governance, configuration, and administration of digital quality tools such as Veeva QMS, ensuring alignment with organizational policies and compliance standards while optimizing system functionality to enhance user experience and operational efficiency
Develop and implement master data management practices to ensure data accuracy, consistency, and integrity across digital quality tools, facilitating informed decision-making and compliance with regulatory requirements
Perform other duties, as assigned
Qualification
Required
Bachelor's degree and 7+ years of Life Science, Engineering, Information Systems, or related experience in a regulated life sciences environment required
7+ years of related experience in Quality Systems, project management, and business analysis
Strong understanding of GxP requirements, Quality System Regulations (QSR), and validation practices
Proven experience managing enterprise system implementations (e.g., Veeva Vault, SAP, etc.)
Experience in business administration for Veeva QMS
Skilled in process modeling, requirements gathering, risk assessment, and stakeholder facilitation
Excellent interpersonal, communication, and organizational skills
Proficient in Microsoft Office, Smartsheet, Teams, and project management tools (e.g., JIRA, MS Project)
Preferred
Master's degree and 5+ years of Life Science, Engineering, Information Systems, or related experience in a regulated life sciences environment preferred
Lean Six Sigma or Agile certification preferred
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeiGene
BeiGene is a global oncology company.
0-1 employees
H1B Sponsorship
BeiGene has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (32)
2023 (39)
2022 (40)
2021 (28)
2020 (16)
Funding
Current Stage
Public CompanyTotal Funding
$6.79BKey Investors
Hillhouse InvestmentAmgenCITIC Capital Holdings,Hillhouse Investment
2020-07-12Post Ipo Equity· $2.08B
2019-10-31Post Ipo Equity· $2.7B
2018-08-02Post Ipo Secondary· $903M
Leadership Team
Dirk Weber
Executive Director Medical Affairs (Europe)
Lai Wang
Global Head of Research and Development
Recent News
2026-01-07
Company data provided by crunchbase