Senior Director, Digital Quality Management Systems (QMS) Strategy and Operations

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:
The Senior Director, Digital Quality Management Systems (QMS) Strategy and Operations, leads the digitalization of the QMS and supports QMS users. This role is responsible for the electronic enterprise Quality applications, ensuring their continuous evolution to meet patient and business needs. Additionally, the role ensures these systems comply with applicable regulations.
 

Essential Functions of the job:

• Develop and oversee the Digital QMS governance model and roadmap to support activities across all product lifecycle phases, ensuring alignment with business needs and the Quality Strategy.

• Act as the system owner for all digital GxP enterprise Quality applications.

• Maintain the Digital QMS in compliance with current regulatory standards while meeting the company’s quality and business objectives.

• Lead electronic system implementations and enhancement projects in collaboration with Business Process Owners and IT.

• Define and maintain a digital quality systems onboarding and training strategy.

• Provide comprehensive oversight of Digital Quality Systems, ensuring effective management, operations, and user adoption.

• Ensure appropriate data quality for systems owned.

• Leverage Artificial Intelligence (AI) capabilities to enhance the company’s digital QMS.

• Develop and maintain business administration processes for Digital Quality Systems.

• Ensure Digital Quality applications are inspection-ready and serve as a Subject Matter Expert (SME) during Health Authority inspections.

• Lead and develop a team of QMS Business Analysts, QMS Project Managers and QMS Operations.

• Act as Quality Lead for cross-functional digital GxP application projects.

• Manage business relationships with suppliers of digital quality applications.

• Promote a strong quality culture, ensuring that digital application implementation and usage are fit for purpose and upholding the highest levels of data integrity and compliance.

• Support the Global Quality leadership team in driving key Quality Culture initiatives.

• Perform other responsibilities as assigned.

Supervisory Responsibilities:  

•  Ensure leadership, guidance and development opportunities for direct reports

Skills and Qualifications:   

• Bachelors degree with 12+ years, Masters with 8+ years, or PhD/PharmD/MD with 6+ years in Quality Assurance in a Pharmaceutical / Medical Device industry in a global environment required.

• Advanced degree in life sciences, computer sciences, quality management, or related field preferred.

• In-depth operational experience in at least one area of the GxP product life cycle, allowing solid understanding of business needs for digital quality applications

• Advanced knowledge of US, EU, ICH and other GxP regulations

• Experience in managing and operating digital quality applications (Veeva preferred)

• Strong leadership, project management, and stakeholder management skills

• Ability to communicate complex information clearly and effectively across business functions
   

Travel:  up to 20% internationally

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

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 and we value diversity. 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.