Senior Director, QA Operations

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Director, QA Operations will oversee and manage global quality assurance activities within the Ultragenyx CMC organization. This role will be responsible for the quality oversight of product manufactured at Contract Organizations for early and late stage clinical programs as well as commercial product. The Sr Director, Quality Operations will maintain and lead continuous improvement of the Product Disposition and Product Quality Complaint Management systems. The successful candidate will ensure product quality operations is compliant with applicable GxP regulations, ICH guidelines, Ultragenyx standards, and industry best practices. This role requires the ability to manage performance and development of direct reports to ensure achievement of organizational and department goals in an engaging and productive environment.

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:

• Ensure on time disposition of Ultragenyx’s multi-product Biologics and Small Molecule portfolio in compliance with cGMPs across various manufacturing stages including cell banks, drug substance, drug product, and finished product
• Coordinate with internal and external Qualified Persons (QP) activities related to QP batch confirmation and batch certification including support of QP queries, QP declarations, and creation and maintenance of the Product Specification File
• Provide Product Disposition quality oversight for New Product Introduction and new country launches in collaboration with CMC teams for management of Supply Chain Maps and compliance to country specific distribution requirements
• Develop, maintain, and enhance Quality Management transactions in Oracle in adherence with global regulatory requirements and serve as the QA representative on Oracle enhancement projects
• Develop and maintain Product Disposition metrics that measure and enhance the performance and health of the Product Disposition quality system and present to Sr Leadership periodically at the Global Quality Systems Management Review
• Ensure significant quality risks are escalated and mitigated in a timely manner
• Manage the Global Product Quality Complaint Handling Unit and drive enhancements to the overall program
• Act as Product Recall coordinator as required
• Facilitate Global Annual Product Review/Product Quality Review in partnership with Quality Leads and collaboration with Tech Ops and Reg CMC
• Represent Ultragenyx to Health Authorities during inspections
• Communicate and promote a culture of quality and operational excellence
• Other duties as assigned

Requirements:

• BS degree in a scientific/technical discipline is required, advanced degree preferred
• Minimum of 15 years’ experience in a GxP biotechnology or pharmaceutical environment is required, Biologics and Small Molecule experience preferred
• Minimum of 8 years’ experience in Quality in a CBER/CDER regulated industry
• Minimum of 8 years’ experience leading and developing high performing teams
• Proficiency in Oracle is desired
• Expert knowledge of cGMP compliance regulations and industry practices
• Demonstrated quality mindset and ability to influence across a matrix organization
• Ability to manage multiple priorities and aggressive timelines
• Experience with Veeva electronic quality management system (eQMS) is a plus
• Travel: approximately 5%  #LI-CS1 #LI-Hybrid