Director, Global Compliance (Open to All Sites - CO, NC, IL or CA)

Overview

**Open to All Sites: Position can be based at any of our office locations which includes: Longmont-Colorado, Durham-NC, Bannockburn/Libertyville-IL or San Diego-CA.**

Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, Inc., a Novartis Company , is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

AveXis is seeking a Director, Global Compliance responsible for establishing and managing the overall GxP compliance program, covering manufacturing, Testing (QC) distribution and clinical activities. This role will guide and oversee the compliance program globally and will lead a team of compliance professionals located at AveXis locations across the US and Europe.

The Director, Global Compliance will lead this team and be responsible for regulatory intelligence, support of regulatory inspections at AveXis sites, design, management and execution of the formal site audit program and critical issue management and management notification processes. Additionally, this role will manage the relationship between AveXis and Novartis' compliance programs, ensuring proper alignment of the two programs.

Responsibilities

• Provide strategic quality input on the compliance aspects of AveXis' Quality System and Quality Assurance activities.
• Plan the globalization of the AveXis compliance program, based on prioritization and risk, across GMP, GDP, GVP, and GCP, GLP operations worldwide.
• 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.
• Act as an expert resource for sites that self-identify potential risks or request solutions for potential compliance issues.
• Work with colleagues at AveXis and Novartis to define the level of alignment or integration that provides maximum benefit, then manage the implementation in accordance with that direction.
• Design and implement Global GxP compliance procedures and standards for optimized efficiency and effectiveness, meeting all appropriate compliance requirements worldwide and optimally supporting and enabling strategic goals.
• Lead the Global Compliance team.
• Work with the Quality Systems teams to contribute to developing robust quality systems, including both implementation and operation at site level, including:
  • SOPs/Document Management: Approve instruction sets, specifications, instructions and other Quality Assurance procedures directly related to GXP activities.
  • Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause.
  • Vendor Management/ Material Release: Ensure all required assessment is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product.
  • Training: Ensure all personnel, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations.
• 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.
• Supports the Quality Systems team to establish a strong quality management review system and the assessment of its adequacy. Assure risks are highlighted to senior leadership, and support cross-site learnings and remediation support as required.
• 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.
• Responsible for product recall management processes and for overall execution of recall process.

Qualifications

• Minimum Bachelor's degree preferably in Microbiology, Chemistry or Biochemistry.
• A minimum of 8 years of experience in bio pharmaceutical based GxP operations.
• 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 reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
• Excellent oral and written communication skills with strong technical writing experience required.
• Experience leading internal site audits (in a global capacity), identify findings, drive resolution and provide closure report.
• 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 30% travel required.

The level of this position will be based on the final candidate's 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 orientation or veteran status.