"Alerted.org

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.