Director, Global Compliance GCP, PV (Greensboro)
Employment Type: Full-Time
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Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.
AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.
Supports the globalization of the AveXis compliance program, based on prioritization and risk, across GLP, GCP and PV operations worldwide.
Responsibilities Execute effectively on the compliance program, conducting audits according to plan, working with colleagues on observation responses and corrective actions to ensure proper and timely completion. Support, execute, and deploy self-inspection program within Avexis. Execute audits of suppliers and Novartis sites as requested by Global Audit planning Act as an expert resource for sites that self-identify potential risks or request solutions for potential compliance issues. Support development and deployment of Global GxP compliance procedures and standards for optimized efficiency and effectiveness, meeting all appropriate compliance requirements worldwide and optimally supporting and enabling strategic goals. Work with the Quality Systems teams to contribute to developing robust quality systems, including both implementation and operation at all sites, including:SOPs/Document Management: Approve instruction sets, specifications, instructions and other Quality Assurance procedures directly related to GXP activitiesDeviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause Contribute to assurance of data integrity. Contribute significantly to site inspection preparation, management and response process. Ensure that corrective actions to inspection observations are propagated through the organization and lead lessons learned exercises to support continuous improvement. Contribute to a monthly Global Quality Management Review meeting (QMR) to review compliance metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.
Qualifications Minimum Bachelor's degree preferably in Microbiology, Chemistry or Biochemistry. A minimum of 10 years of experience in pharmaceutical based GCP and PV operations with 5+ years in a leadership role. Experience with viral gene therapies and/or orphan disease indications is a plus. Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections. Direct experience in GCP and PV auditing, supplier auditing, Health Authority inspection management including preparation of responses and corrective action plans. Excellent oral and written communication skills with strong technical writing experience required. Experience working with sites to improve performance and mitigate risks. Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward. Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence. Approximately 50% travel required.
The level of this position will be based on the final candidates qualifications.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity,national origin, genetics, disability, age, sexual orientationor veteran status.
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