Associate Director, Production and Manufacturing Excellence

Position Summary

The Associate DIR, Production and Manufacturing Excellence at Ultragenyx is responsible for managing deviations, investigations, and CAPAs in Technical Operations, leading Manufacturing Excellence, and serving as a member of the Manufacturing Leadership Team.

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).
• Build and enhance partnerships with key stakeholder groups, including Quality and MSAT, 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.
• 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.
• 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

• 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.

Pay Range

The typical annual salary range for this full-time position is $191,500 USD - $236,600 USD.

Benefits

• Generous vacation time and public holidays observed by the company.
• Volunteer days.
• Long term incentive and Employee stock purchase plans or equivalent offerings.
• Employee wellbeing benefits.
• Fitness reimbursement.
• Tuition sponsoring.
• Professional development plans.