Associate Director, Production and Manufacturing Excellence

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: ultra innovative – Tackle rare and dynamic challenges The  Associate DIR , Production  and  Manufacturing  Excellence,  is  primarily  responsible for the  end-to-end   manag ement of  deviations, investigations,  and  CAPAs  in  support of   T echnical  O perations  and leading a team with  the same   scope of  responsibilities.  Additionally, this role will  have  responsibility for  leading   Manufacturing Excellence  which  encompasses operational performance  mea s ures , production systems governance, quality-system execution, continuous improvement, operational readiness, and manufacturing capability development .  This role ensures robust, compliant, and inspection-ready execution of deviations,  investigations, and  CAPAs   while advancing operational excellence through standardized production systems, performance metrics, and cross-functional  projects and  programs. The position serves as a member of the Manufacturing Leadership Team, driving alignment, performance, and continuous improvement across Manufacturing, site-based Technical Operations, and Quality.   Work Model: Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site. Responsibilities: Ensure consistent, timely, and inspection-ready execution of quality records across Manufacturing, MSAT, Facilities, Engineering, and Supply Chain.     Establish and oversee the strategy, governance, and performance of TechOps quality systems (e.g., deviations, CAPAs, change controls), driving accountability for delivery on key quality metrics and continuous improvement of investigation effectiveness, timeliness, and compliance.   Build and enhance partnership with key stakeholder groups such as Quality and MSAT supporting multiple sites including external manufacturing to share best practices and drive continuous improvement   Lead preparation for regulatory inspections and represent Technical Operations during health authority interactions for quality systems records.    Provide strategic oversight and technical leadership for complex manufacturing investigations and root cause analysis   Define and govern production systems frameworks, standardizing workflows and escalation pathways across Manufacturing, MSAT, QA, and QC   Drive system-level improvements to enhance process robustness and reduce recurrence of deviations   Lead implementation operational excellence initiatives using Lean Manufacturing, Six Sigma, and structured problem-solving methodologies   Contribute to developing strategy and governance for Manufacturing Excellence encompassing:   Reliable execution of manufacturing schedules   Strong right-first-time performance   Operational readiness   Consistent adherence to procedures and business processes   Build, develop, and lead a high-performing team while fostering a culture of accountability, collaboration, and continuous improvement   Requirements: Bachelor’s degree in science, engineering, or related field required    10+ years of experience in biopharmaceutical, biotechnology, or gene therapy manufacturing and 7+ years of management experience.    Demonstrated success leading investigations, CAPA systems, and regulatory inspections or interactions    Deep knowledge of GMP regulations and their application in biologics or gene therapy manufacturing    Proven experience driving operational excellence, continuous improvement, and large-scale process transformation    Strong leadership capability with experience building and developing high-performing teams in Manufacturing, Technical Operations, and/or Quality.    Expertise in root cause analysis and structured problem-solving methodologies (e.g., 5 Whys, Fishbone, Is/Is Not)    Experience with electronic quality systems (e.g., Veeva Vault) preferred   Physical Demand Requirements Non-Manufacturing or Lab Job :    Stand for extended periods of time with periodic stooping / bending / kneeling   Able to lift, push, pull up to 50lbs.   Climb ladders and stairs of various heights.   Work in a lab environment requiring special protective clothing over the head, face, hands, feet, and body. This role requires the ability to wear personal protective equipment.   Certain tasks may require use of a respirator; medical clearance will be required in advance.   #LI-KJ1 #LI-Onsite The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The