Associate Director, Investigations in Bedford

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 Associate DIR, Production and Manufacturing Excellence, is primarily responsible for the end-to-end management of deviations, investigations, and CAPAs in support of Technical Operations and leading a team with the same scope of responsibilities. Additionally, this role will have responsibility for leading Manufacturing Excellence which encompasses operational performance measures, 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, and 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.

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.