Executive Director, Quality Assurance Operations

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:

The Executive Director, Quality Assurance (Operations) will be responsible for Quality Assurance activities related to Drug Substance manufacturing operations at the Gene Therapy Manufacturing Facility (GTMF) located in Bedford, MA.  This role will provide leadership and oversight of a team that supports the core Manufacturing activities for Drug Substance across multiple shifts.  Core activities include the review and approval of manufacturing records, deviation management, change record management, and support of batch disposition activities.  This role partners closely with the Manufacturing leadership team, the downstream Drug Product Quality Assurance team, and cross-functionally with Engineering, Validation, QC, Quality Systems, and MSAT functions to ensure GMP product is made in a compliant manner, with a quality mindset, while maintaining a constant state of inspection readiness.  This role is responsible for quality decisions related to Drug Substance manufacturing operations, material/product movement, and multi-product controls at the site.  This role will also manage the performance and development of direct reports to ensure achievement of organizational and department goals within a product and effective environment.   

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Work Model: 

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

• Lead the Drug Substance QA operations team to create, deploy and manage processes that ensure product quality during manufacturing operations and compliance with applicable FDA/EMA/applicable global health authority requirements and expectations.  This is demonstrated through: 

• • SOPs/Document Management: Approve all instruction sets, specifications, sampling instructions, and other procedures directly related to operations and other cGMP activities 

• • Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause 

• • Raw Material Release: Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product 

• • Training: Ensure all personnel, 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 

• • Validation/Maintenance: Ensure appropriate maintenance and a state of qualification is maintained for equipment and facilities in area of responsibility. 

• Oversee the review and approval of GxP documents, including protocols, Technical Specification (TS), Batch Records, Workbooks, SOPs, and other Quality Management System (QMS) docu