Associate Director, Quality Assurance – Facilities Mgmt.

Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.   If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultrainnovative – Tackle rare and dynamic challenges

This role will be responsible for Quality Assurance oversight of Facilities Management activities related to internal GMP operations at both the Gene Therapy Manufacturing Facility (GTMF) located in Bedford, MA and the Quality Control Laboratories located in Woburn, MA. This role will work closely with the Facilities Management teams at both locations to ensure planned maintenance, unplanned (corrective) maintenance, and calibration activities meet cGMP requirements for the documentation, trending, and escalation of issues. Efforts are focused on ensuring equipment, facilities, and utilities are maintained in a qualified/validated state for Manufacturing and Testing purposes. Core activities include review and approval or maintenance plans, review and approval of unplanned (corrective) maintenance work records, and the development or improvement of maintenance work management processes. This role primarily partners with the Facilities & Engineering teams and closely with Validation, Manufacturing, and Quality Systems. This role will also manage the performance and development of direct reports to support these activities.

Work Model:

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

Responsibilities:

• Provide Quality Assurance leadership and oversight for Facilities Management to create, deploy and manage processes that ensure the facilities, utilities, and equipment are maintained in a qualified/validated state, compliant with applicable health authority requirements and expectations. This is demonstrated through:
  • SOPs/Record Management: Approve maintenance procedures, work instructions, work records, and calibration plans directly related to management of facilities, utilities, and equipment.
  • Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause
  • Validation/Maintenance: Ensure appropriate maintenance and a state of qualification is maintained for equipment, utilities, and facilities in area of responsibility during maintenance work.
  • Training: Ensure all personnel working with Facility Management processes, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations
• Oversee the review and approval of maintenance records such as planned and unplanned (corrective) work requests. Ensure they are adequately assessed for impact and trends are escalated as appropriate.
• Provide oversight of the maintenance management system (e.g., Blue Mountain RAM) to ensure it is efficient and effective for management of maintenance activities. Perform periodic BMRAM audit trail reviews.
• Write, review and/or approve deviations (investigations), CAPA, and change controls associated with Facilities Management.
• Ensure the appropriate capabilities; procedures and quality mindset are in place to ensure GMP with a focus on data integrity / analysis and management
• Develop and maintain Key Quality Performance Indicators for Facility management. Ensure trends are addressed as appropriate.
• Set team objectives in alignment with business objectives and ensures that targets are managed.
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