Director External Quality Assurance

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. We challenge the status quo, create a new model that advances our field, and develop innovative medicines at fair and reasonable prices. We follow the science, apply a novel rapid development approach, and build a collaborative ecosystem to reach patients in ways that are most meaningful for them.

Our commitment to patients extends to our people. Culture is an essential cornerstone at Ultragenyx, and we focus on creating a supportive, inclusive environment of profound learning and growth—so employees can thrive in all areas of their lives, in and outside of work. We aim to be an organization where we would be proud for our family, friends, and children to work.

About the role

The Director, CMC QA will report to the Senior Director of CMC QA and be responsible for maintaining strategic responsibility over QA Manufacturing Operations. This role involves developing and implementing Ultragenyx’s CMC Quality approach for assigned programs, improving processes to ensure product quality, and independently managing external partnerships. In collaboration with key stakeholders in Technical Operations, the Director provides quality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines.

Work Model

Flex: This role typically requires onsite work 2-3 days each week, or more depending on business needs. The business may set specific onsite days for Flex employees.

Responsibilities

• Review and approve investigations of operations in manufacturing, laboratory, or related areas, and lead strategic discussions for operations-related matters.
• Oversee resolution of quality events, monitor recurrent events for proper escalation and resolution, ensure root cause determination, evaluate impact on product quality and disposition, and implement corrective actions.
• Review and approve changes related to facility, computerized systems, laboratory, or products.
• Perform final review of test data and reports to ensure conformance to established specifications and standard operating procedures.
• Drive execution of risk assessments related to manufacturing processes for small molecule, biological products, and novel therapeutics (e.g., mRNA).
• Manage the lifecycle of products within the portfolio according to quality standards.
• Proactively engage with Tech Ops and Tech Development to address qualification and process development requests.
• Develop and maintain procedures and practices in compliance with FDA, EMA, and local regulations, ICH guidelines, Ultragenyx policies, and industry best practices.
• Other duties as assigned.

Requirements

• Bachelor’s degree, preferably in Engineering, Biotechnology, Biological/Physical sciences, or equivalent.
• 10+ years of experience in a GMP biopharmaceutical manufacturing environment in technical operations and/or quality.
• Strong working knowledge and interpretation of FDA, EMA, local regulations and guidelines, Good Distribution Practices, ICH guidelines, and industry best practices.
• Experience using and facilitating risk management tools (e.g., FMEA, PHA).
• Experience performing technical assessments of changes for potential impact to qualification/validation of processes, equipment, utilities, facilities, and systems.
• Capability to collaboratively engage with Contract Organizations.
• Experience in all phases of biologic and small molecule drug development.
• Demonstrated high personal and professional ethical standards.
• Excellent judgment with the ability to think and act quickly, and identify creative solutions to complex technical problems.
• Ability to interpret and relate Quality standards for implementation and review.
• Strong communication skills, both written and verbal.
• Strong organizational and project management skills with a track record of meeting goals and objectives.
• Strong experience with regulatory authority inspections, including both FDA and EMA.
• Travel required (approximately 10%).

Pay

The typical annual salary range for this full-time position is $215,600—$266,300 USD. This range reflects the characteristics of the job and is based on the office location noted in the posting. The range may be adjusted based on the applicant's geographic location. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

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.
• Benefits vary by region and country.