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Senior Manager, Clinical Quality Assurance
1 month ago
Why Choose Ultragenyx?
At Ultragenyx, we believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. Our vision is to lead the future of rare disease medicine by challenging the status quo and creating a new model that advances our field. We follow the science, apply a novel rapid development approach, make innovative medicines at fair and reasonable prices, and create a collaborative ecosystem to reach patients in meaningful ways.
Our Commitment to Patients and People
We remain focused on creating a supportive and inclusive environment of profound learning and growth, so employees can thrive in all areas of their lives. We want to be an organization where we would be proud for our family, friends, and children to work.
Key Responsibilities
The primary responsibility of this role is to provide oversight of GCP activities, ensuring patient safety, data integrity, and compliance with SOPs, GCP, and applicable regulations. Additional responsibilities include execution of the GCP Audit Plan and support of Inspection Management goals and objectives.
Work Model
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, including internal processes, clinical investigational sites, clinical vendors, CSRs, and TMFs. Train, coach, and oversee Clinical QA personnel, subject matter experts, 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. 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, including SOPs, protocols/amendments, study-specific documents, etc., in accordance with applicable regulatory requirements. Provide guidance and support to internal departments and Clinical Study teams in the identification and investigation of potential GCP and compliance issues. 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 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.
