Director External Quality Assurance

Ultragenyx Pharmaceutical•Novato, CA

20h•Hybrid

About The Position

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: ultra focused – Work together to fearlessly uncover new possibilities 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, DIR CMC QA 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.

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 of risk management tools (FMEA, PHA, etc.)
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.

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.