Senior Manager, Clinical Qa
vor 1 Monat
Senior Manager, Clinical QA & GxP ComplianceBrisbane, CA; or Novato, CA
Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.
Position Summary:ultrainnovative – Tackle rare and dynamic challenges 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.Full Time employees across the globe enjoy a range of benefits, including, but not limited to:Generous vacation time and public holidays observed by the company.Long term incentive and Employee stock purchase plans or equivalent offerings.Fitness reimbursement.* Benefits vary by region and country. Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at ******.
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