BeOne Medicines
Associate Director, Digital Quality Management Systems Operations and User Exper
BeOne Medicines, Emeryville, California, United States, 94608
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
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.