Senior Manager, Digital Quality Management Systems

BeiGene, Ltd.; United States; Remote; USD 130,000 - 176,000; Full time

Job summary

An established industry player is seeking a Senior Manager for Digital Quality Management Systems. This pivotal role involves supporting and executing strategies for digital Quality Systems while ensuring compliance with GxP regulations. You will act as a key liaison between Quality, IT, and business stakeholders, driving process optimization and digital transformation initiatives. The ideal candidate will possess extensive experience in project management and business analysis within a regulated life sciences environment. Join a forward-thinking company dedicated to improving patient outcomes and advancing cancer treatment through innovative solutions.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Paid Time Off

Wellness Programs

Employee Stock Purchase Plan

Discretionary Equity Awards

Qualifications

• 7+ years of experience in regulated life sciences environment.
• Proven experience managing enterprise system implementations.

Responsibilities

• Support and execute strategy for digital Quality Systems.
• Manage full lifecycle of system implementations and enhancements.

Skills

GxP Requirements

Quality System Regulations (QSR)

Project Management

Business Analysis

Process Modeling

Risk Assessment

Stakeholder Facilitation

Interpersonal Skills

Communication Skills

Organizational Skills

Education

Bachelor’s degree in Science, Engineering, Information Systems

Tools

Veeva Vault

SAP

Microsoft Office

Smartsheet

Teams

JIRA

MS Project

Job description

Senior Manager, Digital Quality Management Systems page is loaded

Senior Manager, Digital Quality Management Systems

Apply locations Remote (US) time type Full time posted on Posted 2 Days Ago job requisition id R29195

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. 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.

General Description: This position supports and executes the strategy, implementation, and lifecycle management of digital Quality Systems. The Senior Manager, Digital Quality Management Systems acts as a key liaison between Quality, IT, and business stakeholders, ensuring that technology solutions are aligned with business requirements, business goals, and industry best practices. The role balances traditional QMS responsibilities with cross-functional project leadership, system ownership, and process optimization to drive GxP compliance and digital maturity.

• 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/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.
• Perform other duties, as assigned

Skills and Qualifications:

• Bachelor’s degree in Science, Engineering, Information Systems, or related field; or equivalent experience.
• 7+ years of experience in a regulated life sciences environment.
• 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.).
• Skilled in process modeling, requirements gathering, risk assessment, and stakeholder facilitation.
• Proficient in Microsoft Office, Smartsheet, Teams, and project management tools (e.g., JIRA, MS Project).
• Excellent interpersonal, communication, and organizational skills.
• Lean Six Sigma or Agile certification preferred.

Travel: Occasional travel, domestic and international (up to 15%) may be required

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: $130,600.00 - $175,600.00 annually

BeOne 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 BeiGene, 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.