Senior Manager QA Operations Drug Substance (M-F, 2:30 pm - 10:00 pm)

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:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Manager of Quality Assurance Operations Drug Substance will be responsible for Quality oversite of the Gene Therapy Manufacturing Facility (GTMF) Drug Substance manufacturing area.  This individual will operate with a quality mindset and provide "on the floor" oversite of manufacturing activities which includes but is not limited to "on the floor" guidance during unexpected events, batch record review, line clearance, and deviation and change control management.  You will partner with Manufacturing, Engineering, Facilities, MSAT, Validation, and Quality Control teams to support manufacturing and product release activities as well as ongoing projects, initiatives and reports.  You will provide quality expertise to ensure compliant manufacture of GMP material (clinical or commercial).  In this role, operational excellence initiatives must be supported and driven. Supervision and mentoring of junior level team members to clarify goals and priorities may be required. You will be required to set goals for your team and ensure the team is supported and trained to meet those goals. 

Work Model:

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

Responsibilities:

1. Must demonstrate the ability to manage deviation/CAPA records and may be required to function as a deviation/CAPA manager for minor or major deviations as needed. 
2. Will be required to review Change Control Records as needed. 
3. Will be required to own various Quality procedures and ensure the systems/processes are deployed effectively.  Will contribute to Quality Assurance program policies and procedures related to their area. 
4. Review/Approval of Master Batch Records and review/approval of executed DS Production Batch Records. 
5. Perform QA review/approval of Drug Substance area shutdowns/restarts after planned or unplanned maintenance/EM events etc. 
6. Responsible for writing, reviewing and/or approving documents such as SOPs, work instructions, policies, and standards to enable the execution of GMP manufacturing. 
7. Work with various functions to resolve deviations and assess potential product and compliance impact. Escalate significant events to Quality Management and drive timely completion of effective investigations. 
8. Perform routine area walkthroughs, logbook reviews, inspection readiness assessments. 
9. Drive or support continuous improvement activities to support elimination of waste to enable an effective and efficient manufacturing site/process. Champion process improvement where applicable. 

Requirements:

1. Advanced technical and regulatory understanding of Drug Substance manufacturing, (Formulation, Filling, Aseptic Operations, Vial Inspection/AQL, Packaging & Label