Director, CMC Quality Assurance

Position Summary:

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The Director, CMC QA will report to the Senior Director of CMC QA and be responsible for maintaining strategic responsibility over QA Manufacturing Operations, developing and implementing Ultragenyx CMC Quality approach for assigned programs, and working with colleagues to improve processes utilized to ensure product quality. In addition, this position will use strong management skills to independently manage external partnerships.

In this role, in collaboration with key stakeholders in Technical Operations, you will provide 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 will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

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

Requirements:

• Bachelor’s degree preferably in an 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 practice.
• Experience using and facilitating use or risk management tools (FMEA, PHA, etc.)
• Experience leading and participating in investigations into manufacturing and analytical deviations and determination of product impact, root cause, and corrective and preventive actions.
• Experience with performing technical assessment of changes for potential impact to qualification/validation of processes, equipment, utilities, facilities, and systems.
• Capability of collaboratively engaging with Contract Organizations.
• Experienced in all phases of biologic and small molecule drug development.
• Demonstrated high personal and professional ethical standards.
• Possesses excellent judgment with the ability to think and act quickly. Must be able to identify creative solutions to complex technical problems.
• Ability to interpret and relate Quality standards for implementation and review.
• Ability to communicate clearly and professionally both in writing and verbally.
• Strong organizational and project management skills with a track record of meeting goals/objectives.
• Strong experience with regulatory authority inspections, including both FDA and EMA.
• Travel will be required when appropriate (approximately 10%) #LI-CS1 #LI-Hybrid