Associate Director, Investigations

About the Role

Join Ultragenyx to make a significant impact on rare disease patients by leading investigations, deviations, and corrective action/preventive action (CAPA) processes within Technical Operations. This full-time, onsite position based in Bedford, MA, entails managing a team responsible for quality systems governance and manufacturing excellence across production and technical operations. Ultragenyx values innovation by challenging industry norms to deliver novel biopharmaceutical treatments diligently and affordably while fostering an inclusive, growth-oriented workplace.

Key Responsibilities

• Manage and ensure timely, compliant, and inspection-ready execution of quality records spanning Manufacturing, MSAT, Facilities, Engineering, and Supply Chain functions.
• Develop and lead strategy and governance of Technical Operations quality systems, including deviations, CAPAs, and change controls, improving investigation effectiveness and compliance.
• Partner with Quality and MSAT teams across multiple internal and external manufacturing sites to standardize best practices and promote continuous improvements.
• Lead preparation and representation during regulatory inspections and health authority interactions concerning quality systems records.
• Provide technical leadership for complex manufacturing investigations and root cause analyses.
• Define and oversee standard production system workflows and escalation processes across Manufacturing, MSAT, QA, and QC.
• Drive initiatives to improve process robustness and minimize deviation recurrence.
• Champion operational excellence projects leveraging Lean Manufacturing, Six Sigma, and structured problem-solving approaches.
• Contribute to the development and oversight of Manufacturing Excellence strategies focusing on schedule reliability, right-first-time performance, operational readiness, and adherence to procedures.
• Build and lead a high-performing team cultivating accountability, collaboration, and ongoing improvement.

Qualifications

• Bachelor's degree in science, engineering, or a related discipline.
• Over 10 years of experience in biopharmaceutical, biotechnology, or gene therapy manufacturing, including at least 7 years in leadership roles.
• Proven success managing investigations, CAPA programs, and regulatory inspections.
• Deep expertise in GMP regulations applicable to biologics or gene therapy manufacturing environments.
• Demonstrated ability to drive operational excellence, continuous improvement, and transformative process changes.
• Strong leadership skills with experience developing and managing manufacturing and quality teams.
• Proficient in root cause analysis and structured problem-solving techniques (e.g., 5 Whys, Fishbone diagrams, Is/Is Not analysis).
• Experience with electronic quality management systems such as Veeva Vault preferred.

Physical Requirements

• Ability to stand for extended periods and perform occasional bending, stooping, kneeling.
• Capable of lifting, pushing, or pulling up to 50 pounds.
• Comfortable climbing ladders and stairs of varying heights.
• Work in laboratory settings requiring personal protective equipment including full-body coverings.
• May require use of respirators, subject to medical clearance.

Compensation & Benefits

The annual salary range offered for this full-time position is $191,500 to $236,600 USD, adjustable based on skills, experience, and geographic location. Eligibility for annual bonuses and equity incentives is included. Benefits encompass generous vacation and public holidays, volunteer days, long-term incentives, employee stock purchase plans, wellness programs, fitness reimbursements, tuition sponsorship, and professional development opportunities. Regional variations in benefits may apply.

Cultural Commitment

Ultragenyx fosters a culture of diversity, inclusion, and ethical leadership, providing reasonable accommodations for protected groups and supporting employees' holistic well-being. The company prohibits unlawful discrimination and adheres to applicable federal, state, and local laws.

Additional Information

Recruiting communications and candidate submissions are managed solely via the Human Resources Department. Direct contact with employees or hiring managers from external recruiters is discouraged unless formal agreements are in place. Applicants needing accommodations during the hiring process are encouraged to contact Talent Acquisition.