The Director, Quality Systems provides expertise with respect to the monitoring, maintenance, and continuous improvement of the Quality Management System (QMS). Systems include but are not limited to training, document control, Veeva Vault administrator and management of deviation, CAPA, and change control workflows. Additional responsibilities include supporting internal, third party, and regulatory agency audits and inspections.

PRINCIPAL DUTIES:

·       Manages the Quality Training, Documentation Control, Administration of Veeva Vault and QMS GxP Operations.

·       Facilitates continuous improvement initiatives to transform QMS business processes, maintain compliance, and improve business process efficiency.

·       Develops and delivers training to support consistent and effective execution of the Quality Management System, including but not limited to deviations, CAPAs, and change controls.

·       Monitor workflows and training records to ensure users complete tasks in a timely manner.

·       Work as a Veeva subject matter expert, troubleshooting technical issues identified during document processing in the document management system.

·       Participates in inspection readiness and inspection support activities.

·       Compiles and provides applicable metrics related to document processing and for periodic Quality Management Review meetings.

·       Develops and maintains role-based curricula and issues training assignments as well as supports maintenance and improvements to the Veeva learning management system

·       Conducts internal audits of the electronic document management and learning management system and documents where needed to ensure compliance with applicable policies and SOPs.

·       Collaborates cross-functionally to create, manage, and report on Key Performance and Key Quality Indicators (KPI and KQI) and trends.

·       Represents Quality Assurance on project teams and in meetings.

·       Promotes a Quality Culture by supporting innovation, teamwork and efficiency within the organization.

·       Other responsibilities as assigned.

REQUIRED QUALIFICATIONS/EXPERIENCE:

• Minimum 10+ years of experience in pharmaceutical/biopharmaceutical document control, experience that spans clinical development through commercial distribution is preferred.
• Experience with electronic document management and learning management systems is required.
• Experience implementing and administering Veeva Quality modules.

• Advanced knowledge of GxP standards and documentation requirements.
• Excellent skills within MS Word and Office suite.
• Excellent verbal and written communication skills to communicate effectively.
• Strong organizational skills, attention to detail, and knowledge/experience with electronic data management and data integrity.
• Experience with Regulatory documentation and Regulatory submissions particularly within the Veeva RIM module is a plus.
• Ability to manage multiple tasks in parallel.
• Batchelor’s Degree required.