Position Summary:

Ultragenyx is looking for a Director, Global Compliance Audit, to execute the external audit program, internal self-inspection program and support the audit lifecycle for vendors and suppliers. The candidate will communicate assessments of compliance and inspection risks to support business critical decisions that may impact Quality and Regulatory timelines and decisions.

The ideal candidate has experience as a Quality or Operations (Manufacturing and/or QC) professional, GxP Compliance Auditing of pharmaceutical manufacture/testing/distribution, identifying and developing procedures and process improvements, analyzing Corrective Action/Preventative Action plans, is self- managed and able up to 50% to travel for domestic and international audits.

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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:

• Lead and participate in GxP (GMP/GDP/GLP/GVP) compliance audits. Author, review and approve audit reports
• Assess the effectiveness of corrective actions in response to internal and external audits and negotiate improved CAPA plans with audit stakeholders
• Provide compliance oversight to ensure product quality during operations and adherence to applicable global Health Authority regulations, requirements and expectations
• Determine and inform Executive Leadership when potential Quality and/or regulatory issues at CMOs may impact product quality, patient safety, supply chain, and/or regulatory compliance
• Develop, review, and approve department specific SOPs and corporate standards in support of the Quality Management System
• Communicate department metrics and monitor performance
• Serve as a Compliance representative on cross-functional and multi-site teams and provide compliance interpretation of GxP to clinical and commercial operations
• Lead and partner with external contract organizations and internal stakeholder departments to drive continuous improvement of audit processes, procedures and product quality
• Foster an environment of accountability, diversity and speaking up
• Effectively collaborate with internal operations and external 3rd parties to execute

Requirements:

• Bachelor's Degree is required in Biological Science, Chemistry or related technical discipline
• 10+ years’ experience in Biotech/Pharmaceutical industry
• Strong working knowledge and interpretation of FDA, EMA, MHRA, ICH and other global regulations and guidelines
• Experience with GxP auditing practices and methodology
• Familiar with all phases of biologic/gene therapy/mRNA drug development
• Demonstrates high personal and professional ethical standards
• Experience with computerized systems and compliance requirements
• Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections is a plus
• Experience working with contract manufacturing, laboratory and distribution organizations is a plus
• Strong organizational and project management skills with a track record of meeting goals/objectives
• Strong teamwork, interpersonal skills and negotiation skills, both internally and externally
• Flexible work schedule to accommodate program priorities and international activities as needed
• This is a Flex role, which will typically require onsite work 2-3 days each week, or more depending on business needs, with up to 50% travel, both domestic and international, required

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