BeOne Medicines I GmbH is hiring a Senior Manager, Digital Quality Management Systems, Business Analyst

BeOne Medicines I GmbH is hiring a Senior Manager, Digital Quality Management Systems Business Analyst. In this role, you will be responsible for supporting and executing the strategy, implementation, and lifecycle management of digital Quality Systems. You will serve as a key liaison between Quality, IT, and business stakeholders, ensuring technology solutions align with business requirements, goals, and industry best practices.

What You'll Do

• Serve as the business System Owner for assigned Quality GxP digital systems such as eQMS and QualityDocs.
• Lead and manage the 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 the Quality organization.
• Collaborate with cross-functional teams including QA, IT, Regulatory, Clinical, and external vendors.
• Develop and maintain strong relationships with business process owners.
• 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.
• Develop and implement master data management practices to ensure data accuracy, consistency, and integrity.

What We're Looking For

• Bachelor’s degree and 7+ years of Life Science, Engineering, Information Systems, or related 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 such as Veeva Vault or SAP.
• Experience in business administration for Veeva QMS.
• Skilled in process modeling, requirements gathering, risk assessment, and stakeholder facilitation.
• Excellent interpersonal, communication, and organizational skills.

Nice to Have

• Master’s degree and 5+ years of Life Science, Engineering, Information Systems, or related experience in a regulated life sciences environment.
• Lean Six Sigma or Agile certification.

Technical Stack

• Microsoft Office, Smartsheet, Teams
• Project management tools such as JIRA and MS Project
• Veeva QMS

Team & Environment

You will act as a key liaison between Quality, IT, and business stakeholders. The role involves collaborating with cross-functional teams including QA, IT, Regulatory, Clinical, and external vendors.

Benefits & Compensation

• Compensation range: $133,200.00 - $178,200.00 annually.
• All employees are eligible for discretionary equity awards.
• Medical, Dental, Vision insurance.
• 401(k).
• FSA/HSA.
• Life Insurance.
• Paid Time Off.
• Wellness programs.
• Eligibility for Employee Stock Purchase Plan.
• Non-Commercial roles eligible for annual bonus plan.
• Commercial roles eligible for incentive compensation plan.

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.