Associate Director Clinical Quality Assurance and GxP Compliance

Position Summary:

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The CQA Associate Director provides strategic leadership and direction for the creation, development, and continuous evolution of quality assurance strategies, policies, programs, and initiatives. They are accountable for ensuring that organizational decisions, activities, and deliverables align with established quality standards and global health authority regulations. The Associate Director partners with senior leadership and cross-functional stakeholders to proactively evaluate and enhance quality systems, strengthen inspection readiness, and drive enterprise-wide process improvements. They champion and model a culture of compliance and quality excellence across the organization. They provide high-level oversight, guidance, and governance for the GCP Audit Program, ensuring effective planning, execution, resourcing, and risk mitigation. The Associate Director also identifies strategic opportunities to enhance operational efficiency, advance quality maturity, and support organizational growth. 

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:

• Serve as a senior subject matter expert (SME) on U.S. FDA, EMA, and ICH-GCP regulations, providing strategic oversight and guidance to Ultragenyx functional leaders. Direct the evaluation of non-compliances and risk areas across clinical programs and drive development of sustainable, cross-functional solutions. 
• Provide leadership, mentorship, and strategic direction to QA personnel, SMEs, and contract service providers in the preparation, conduct, and reporting of GCP audits. Ensure capability building that aligns with organizational needs and evolving regulatory expectations. 
• Oversee and govern the execution of all GCP audit types, including complex or high-risk audits (e.g., For-Cause, systemic failure evaluations). Ensure appropriate audit strategy, resourcing, and escalation pathways to support enterprise-level risk management. 
• Serve as the senior SME representing Clinical Quality during regulatory inspections, providing leadership on issue presentation, regulatory interactions, and cross-functional coordination. Oversee the creation, review, and approval of storyboards and inspection narratives. 
• Establish, direct, and oversee the enterprise Clinical Program Inspection Readiness strategy, including risk-based identification of key vendors and sites, mock inspections, war room preparation, and readiness governance. Ensure proactive alignment with Health Authority expectations. 
• Act as the executive CQA liaison to Records & Document Management and the Site Management Liaison (SML) team, steering continuous improvement of TMF management, clinical oversight processes, and documentation culture. Provide strategic direction to enhance regulatory compliance and operational effectiveness across teams. 
• Lead and prioritize Quality initiatives and department-level continuous improvement programs, ensuring alignment with organizational strategy, regulatory trends, and quality maturity objectives. 

Requirements:

• Bachelor's Degree is required in a scientific or related technical discipline. 

• At least 7+ years' experience in health-care field or setting, or in Biotech/Pharmaceutical industry with 3-6 years Quality Assurance or Compliance experience preferred. 

• Able to establish and execute Quality goals for a forward-looking 3-5 year period that aligns to company-wide objectives. 

• Broad and direct experience with leading or organizing regulatory authority inspections. 

• Strategic thinker, open-minded and flexible to adopting new ideas. 

• Excellent communications skills, both written and verbal. 

• Flexible in the face of shifting needs and/or priorities. 

• Travel: approximate 30% (if needed). 
• Partner & Collaborate Effectively: Listen to and value others’ thoughts and ideas. Demonstrate effective partnership both within and outside your team. Achieve results with and through others.
• Support Learning & Growth: Demonstrate self-awareness, humility, and curiosity in service of self-development. Provide regular coaching and feedback that will inspire growth and improvement in others. 

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