Associate Director, Quality Assurance Document Control Management

This role will ensure the effective and efficient execution of the electronic document management system (EDMS) and associated document and record management processes at both the Gene Therapy Manufacturing Facility (GTMF) located in Bedford, MA and the Quality Control Laboratories located in Woburn, MA. This role will develop and deploy processes that ensure data integrity of quality records. Core activities include document revisions, document archival, and control of document issuance and reconciliation. This role will partner with all functional teams located at both locations and will manage the performance and development of direct reports to support these activities.

ultraimpact – Make a difference for those who need it most

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site

• Lead the Document Control Team and assist in managing the day-to-day activities of staff
• Ensure documents and Document Change Controls are routed through the Electronic Document Management System (EDMS); monitor status of workflows
• Ensure the periodic review process for controlled documents is completed in a timely manner and documents are revised as required; follow up with task owners as needed
• Manage the issuance and reconciliation of controlled forms utilized to record original data (e.g., batch records and test data sheets)
• Develop metrics that monitor the execution of the document management processes. Generate reports, identify and escalate trends as applicable
• Ensure document and record management storage areas are maintained in an organized manner. Manage document retention, archival, and destruction processes per applicable procedures
• Collaborate with the EDMS global community (including document authors and area training leads) to ensure alignment, consistency, and continuous improvement
• Participate in internal audits or health authority inspections at the site; facilitate the completion of responses and completion of applicable actions
• Set team objectives in alignment with business objectives and ensure that targets are achieved
• Drive continuous improvement initiatives to enhance document management
• Foster an environment of accountability, diversity and speaking up
• Perform any other tasks as requested by management to support Quality oversight activities
• Manage and administer all aspects of people processes related to the employee life cycle. Coach and develop staff, set realistic personal goals for self and staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities
• Actively partner with the Global Document Control Team to support adherence to the Document Management principles

• Minimum of a Bachelor’s Degree in a science, engineering, or related technical discipline
• 8+ years of experience in biopharmaceutical, biotechnology, or related life-science industry with GMP operations
• Experience implementing and managing Electronic Document Management Systems (EDMS) in a validated GMP environment; preferably Veeva
• 4+ years of direct supervisory experience of technical or quality professionals with demonstrated effectiveness to recruit, hire, and training and the ability to provide continued guidance, mentorship and support to staff
• Able to define and implement system health measurements
• Must be able to proactively provide real-time resolutions and approaches balanced with long-term objectives
• Strong organizational and project management skills with a track record of meeting goals/objectives
• Proficiency with data analysis tools to identify trends
• Detail-oriented with a commitment to quality and compliance
• Excellent verbal and writing communications skills
• Excellent teamwork, interpersonal skills, influencing skills and negotiation skills
• Travel may be required up to 10%. Most travel will be between Ultragenyx locations located in Boston or San Francisco areas

#LI-CS1 #LI-Hybrid