Director, CMC Quality Assurance

Position Summary:

ultraimpact - Make a difference for those who need it most

The Director, CMC QA will report to the Executive Director of CMC QA and be responsible for maintaining strategic responsibility over QA Operations, developing and implementing Ultragenyx CMC Quality approach for assigned Gene Therapy 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, Regulatory Affairs and extended Quality (ie. QC, Supplier Quality), 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 at GTMF and/or contract manufacturing organizations (CMO).

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

• Quality Assurance Lead for the cross-functional CMC Sub-Teams

• Influence the overall CMC development strategy throughout the product lifecycle based on current industry standards and health authority guidances

• Ensure GMP processes are implemented in the Quality Management System (QMS) for clinical and commercial product process lifecycle (e.g. control strategy, technology transfer, process validation lifecycle, continuous process verification)

• Provide oversight to ensure the creation of product characterization, product specifications, method validation, stability, and comparability assessments for technology transfers are in accordance with global regulatory requirements and internal procedures/policies

• Develop, approve, monitor and maintain critical quality standards to proactively minimize product quality risks, including application of controls supporting risk-based continued process verification and monitoring of lifecycle product quality

• Provide strategic guidance and quality support for significant changes and issue management (Deviations/CAPA)

• Author/review CMC sections of relevant regulatory dossiers and strategize responses to regulatory agency queries and Qualified Person (QP) queries throughout the product lifecycle

• Represent Ultragenyx to Health Authorities as a product quality expert

• Communicate and promote a culture of quality and operational excellence

• Other duties as assigned

Requirements:

• BS degree preferably in an Engineering, Biotechnology, Biological/Physical sciences or equivalent.

• Minimum of 12 years 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 CMO's.

• Experienced in all phases of biologics, gene therapy, and/or cell therapy drug development.

• Demonstrated high personal and professional ethical standards.

• Possesses excellent judgement with the ability to think and act quickly. Must be able to identify creative solutions to complex technical problems.

• Abilit 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 fo meeting goals/objectives.

• Strong experience with regulatory authority inspections, including FDA and EMA.

• Travel may be required when appropriate (approximately 10%).

• Expert knowledge of cGMP compliance regulations and industry practices for US/Ex-US #LI-CK1 #LI-Onsite