Associate Director, Digital Quality Management Systems Operations and User Experience

BeiGene; United States; Remote; USD 137,000 - 188,000; Full time

Job summary

A leading company in the pharmaceutical sector seeks an Associate Director for Digital Quality Management Systems. This role focuses on optimizing digital quality applications, ensuring compliance and enhancing user experience. Candidates must possess strong leadership and project management skills, with extensive experience in Quality Assurance. The position offers competitive compensation and benefits in a collaborative work environment.

Benefits

Comprehensive benefits package including Medical, Dental, Vision

401(k)

Paid Time Off

Employee Stock Purchase Plan

Discretionary equity awards

Qualifications

• Minimum of 8+ years in Quality Assurance in Pharmaceutical/Medical Device industry.
• In-depth operational experience in GxP product life cycle.
• Advanced knowledge of US, EU, ICH and other GxP regulations.

Responsibilities

• Oversee daily operations of digital QMS applications.
• Develop user support framework including training materials.
• Ensure compliance with regulatory requirements.

Skills

Leadership

Project Management

Stakeholder Management

Analytical Thinking

Data Analysis

Education

Bachelor's degree in life sciences, computer sciences, quality management, or related field

Advanced degree preferred

Tools

Veeva

Job description

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 Associate Director, Digital Quality Management Systems (QMS) Operations and User Experience, is responsible for ensuring the efficient operation, support, and continuous improvement of enterprise digital quality applications. This role plays a key part in enhancing user experience by optimizing system performance, streamlining processes, and delivering comprehensive support and training. The Associate Director works closely with business users, IT teams, and quality stakeholders to drive adoption, ensure compliance, and improve the effectiveness of digital quality tools.

Operational Excellence & System Performance

• Oversee daily operations and business administration of digital QMS applications to ensure reliability, efficiency, and compliance.

• Monitor system performance and issue resolution, working closely with IT and vendors to minimize disruptions.

• Identify and implement process improvements to enhance system usability and operational efficiency.
  

User Experience & Support

• Develop and maintain a user support framework, including training materials, troubleshooting guides, and best practices.

• Act as the primary business point of contact for QMS users, ensuring timely resolution of system-related issues and questions.

• Gather user feedback to drive enhancements and optimizations in digital quality applications.
  

Training & Adoption

• Design and implement onboarding and training programs to enhance user adoption and competency with digital quality systems.

• Conduct user engagement initiatives, including webinars, workshops, and documentation to improve system utilization.

• Establish a knowledge base and self-service tools to promote efficient system usage.
  

Compliance & Continuous Improvement

• Ensure digital QMS applications remain compliant with regulatory requirements (e.g., US, EU, ICH GxP).

• Work cross-functionally to implement AI-driven and automated solutions that improve system functionality.
  

Stakeholder & Vendor Collaboration

• Partner with IT, Quality, and Business Process Owners to align digital QMS functionality with business needs.

• Support system upgrades, enhancements, and change management processes.
  

Additional Responsibilities

• Promote a culture of continuous improvement by identifying and implementing best practices.

• Assist in the development of digital QMS governance and strategy, ensuring alignment with business objectives.

• Perform other responsibilities as assigned.

Supervisory Responsibilities:

• Ensure leadership, guidance and development opportunities for direct reports

Computer Skills:

Skills and Qualifications:

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

• Minimum of 8+ years in Quality Assurance in a Pharmaceutical / Medical Device industry in a global environment

• 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: Occasional travel domestic and international (up to 5%) 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: $137,200.00 - $187,200.00 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 BeOne Medicines 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.