The primary responsibility of this role is to provide oversight of GCP activities which include, but are not limited to: ensuring patient safety, data integrity and compliance with SOPs, GCP and applicable regulations. Additional responsibilities include execution of the GCP Audit Plan as well as support of Inspection Management goals and objectives.

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:

• Plan, conduct or manage, and report results for GxP audits which includes but is not limited to internal processes, clinical investigational sites, clinical vendors, CSRs and TMFs.
• Train, coach and oversee Clinical QA personnel, subject matter experts (SMEs) and/or other contract service provider(s) in preparing, conducting, and reporting of GxP audits, as assigned
• Actively support inspection readiness activities, associated Health Authority Inspections and perform assigned War Room leadership role through the following:
  • Participate in cross functional teams to identify GxP inspection risks and lead activities to mitigate and defend business processes, for example through storyboard process
  • Identify and communicate potential risks
  • Develop and deliver inspection training for SMEs and War Room support team members
  • Lead partnerships with key stakeholders to deliver forward-thinking programs and training facilitating a state of inspection readiness
• Review GCP-associated controlled documents which may include standard operation procedures (SOPs), protocols/amendments, study-specific documents such as study or data management plans, etc., in accordance with applicable regulatory requirements (e.g., ICH E6, U.S. FDA, EMA, and local regulations)
• Provide guidance and support to internal departments and Clinical Study teams (during all phases of clinical development) in the identification and investigation of potential GCP and compliance issues, including those at clinical investigator sites, with internal Ultragenyx processes, and with vendors conducting GCP activities.
• Ensure appropriate and timely solutions for corrective and preventive actions are implemented at sites or vendors, when needed to secure compliance and maintain a state of inspection readiness.
• Ensure proper evaluation and completeness of deviation/CAPA entries; project manage process to ensure timely completion and closure of deviations/CAPAs, to ensure triage and report metrics and trends to management.
• Perform any other tasks as requested by Clinical QA and/or Executive Management to support Quality oversight activities

Requirements:

• Bachelor's Degree is required in a scientific or related technical discipline
• At least 7+ years’ experience in Biotech/Pharmaceutical industry, Quality Assurance experience preferred
• Strong working knowledge and interpretation of global GCPs, particularly U.S. FDA / EU and ICH regulations and guidelines
• Able to execute quality goals over a 1-2 year period that aligns to company-wide objectives.
• Excellent communications skills, both written and verbal
• Flexible in the face of shifting needs and/or priorities
• Motivated, committed and self-managed
• Travel up to 30% of the time #LI-CS1 #LI-Hybrid