Vice President, Quality Systems and Compliance

Employer
AveXis Inc.
Location
Durham | US-IL-Libertyville, NC, US
Posted
Sep 18, 2019
Ref
2019-4203
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

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.

AveXis is seeking a Vice President of Quality Systems and Compliance (QS&C) responsible for leadership of the design and implementation of Integrated Quality Systems for AveXis GXP operations worldwide, and compliance to these requirements, local regulation and appropriate Novartis requirements, standards and systems. This role will lead the group responsible for the architecture of these systems, integration with Novartis Quality Systems and standards and will lead a team to author or contribute to the procedures governing these systems. The VP, QS&C will work towards timely implementation, providing expertise and participating fully in the management of health authority inspections. Close collaboration with both Avexis and Novartis colleagues is essential to the success of this role.

Responsibilities

  • Provide senior quality leadership to the Quality Systems and Compliance functions.
  • Serve as a senior member of the Global Quality Team for AveXis.
  • Provide strategic quality input on the design and architecture of AveXis' Quality System.
  • Plan, implement and operate the Novartis integrated Quality Systems for AveXis.
  • Define, build and lead effective teams for the management of Global Quality Systems and Global Compliance at AveXis.
  • Define the level of alignment or integration that provides maximum benefit, then manage the implementation in accordance with that direction.
  • Engage fully with Novartis functions responsible for Quality Systems management and Compliance Management to deliver upon agreed objectives and outcomes.
  • Plan the globalization of the AveXis Quality System, based on prioritization and risk, across GMP and GCP operations worldwide.
  • Design and implement Global GXP Quality Systems at AveXis, for optimized efficiency and effectiveness, meeting all appropriate compliance requirements worldwide, at the same time optimally supporting and enabling the strategic goals of AveXis.
  • Work with the AveXis Data Integrity Officer, by contributing to assurance of data integrity through review of paper and electronic raw data.
  • Ensure inspection preparation, management and response process readiness through own team and close collaboration with Quality Site Heads.
  • Establish a strong quality management review system and the assessment of its adequacy. Participate in Periodic conformance audits of the operations of the system.
  • Jointly with Quality Operations colleagues, create and maintain a monthly Global Quality Management Review meeting (QMR) to review metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.
  • 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 both 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 at AveXis, for optimized efficiency and effectiveness, meeting all appropriate compliance requirements worldwide, at the same time optimally supporting and enabling the strategic goals of AveXis.


Qualifications

  • Minimum Bachelor's degree preferably in Microbiology, Chemistry or Biochemistry.
  • A minimum of 15 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 audits, identifying findings, driving resolution and providing closure report.
  • Ability to synthesize data and summarize outcomes to provide recommendations on a 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.