Associate Director, Analytical Quality Assurance

The Associate Director, Analytical Quality Assurance, will partner with team members across Quality Assurance, Quality Control, and Technical Operations to ensure effective, efficient, and compliant operations exist at our GMP facility. The individual will nurture and reinforce the Ultragenyx Responsible Quality Mindset and Quality Culture at UGT (Ultragenyx Gene Therapy). This role will be responsible for Quality Assurance oversight of QC Environmental Monitoring and Raw Materials activities related to GMP operations at the Gene Therapy Manufacturing Facility (GTMF) located in Bedford, MA. Core activities including approval of applicable procedures, work instructions and records directly related to QC Environmental Monitoring and Raw Materials and driving the completion of robust deviations (investigations), CAPA, and change controls associated with the QC and AQA groups at GTMF. This role will also manage the performance and development of direct reports to support these activities.

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

• Provide Quality Assurance oversight for Analytical Quality Assurance to deploy and manage processes that ensure compliance with the QC Environmental Monitoring and Raw Material areas
• Approve applicable procedures, work instructions and records directly related to QC Environmental Monitoring and Raw Materials
• Write, review and/or approve deviations (investigations), CAPA, and change controls associated with the QC and AQA groups at GTMF
• Ensure the appropriate capabilities; procedures and quality mindset are in place to ensure GMP with a focus on data integrity / analysis and management
• Provide active support for QC EM and RM operations inclusive of associated facilities, lab operations and IT operations
• Facilitate resolution of facility excursions by participating in the cross-functional review committee
• Ensure raw materials sampling and testing programs are operating in an appropriate state for the product lifecycle stage
• 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
• Participate in inspections and audits for various roles as assigned

• Minimum B.S. degree in a scientific field such as microbiology, chemistry or biochemistry
• 8+ years of experience in biopharmaceutical, biotechnology, cell or gene therapy industries within Quality roles. 2+ years of Quality leadership/management experience
• Demonstrated experience with creating and implementing effective cGMP quality systems, inclusive of writing SOPs, work instructions, maintenance procedures, and maintenance plans
• Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections
• Excellent communications skills, both written and verbal
• Excellent teamwork, interpersonal skills and negotiation skills
• Willingness to work in a dynamic and changing corporate environment. Flexible in the face of shifting needs and/or priorities
• Travel may be required up to 10%. Most travel will be to other Boston-area locations for larger team meetings

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