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Manager, Quality Assurance Compliance

Employer
Novartis Gene Therapies
Location
Durham, NC, US
Start date
Jun 20, 2019

View more

Discipline
Quality, Quality Assurance, Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC
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 Manager, Quality Assurance Compliance responsible for designing and implementing robust Quality Systems for an AveXis gene therapy manufacturing site, considering global and local requirements of the company. This role will contribute significantly to the architecture of these systems, will author or contribute to the procedures governing these systems and will work towards timely implementation, providing expertise and participating fully in the management of health authority inspections.

Responsibilities

  • Manage the regulatory inspection process at the site level.
  • Quality lead for inspection strategies, preparation and interactions.
  • Monitor industry observations and trends as a preventive tool to ensure compliance.
  • Develop internal audit schedule and manage internal audit performance, follow-up, and escalation of significant observations.
  • Develop and manage a risk management program at the site level, including management of a site quality risk register.
  • Manage the dissemination of regulatory intelligence from global to site responsibilities, including the following activities:
    • Identify processes and procedures that may be affected by a regulatory requirement update.
    • Partner with functional area management to revise any related documentation.
    • Partner with Training to identify training needs to support the change(s).
  • Manage the site process for Biological Product Deviation (BPD) reporting.
  • Act as a liaison between Regulatory Affairs and site communication, as needed.
  • Lead the site Quality Management Review meeting.
  • Develop, track, trend, and report key performance indicators (KPI) to ensure continuous quality improvements.
  • Serve in a consulting manner on issues that may have quality or compliance impact.
  • Work with Global Quality to ensure best practices are shared with other sites.
  • Provide subject matter expertise during audits and regulatory inspections, as necessary.


Qualifications

  • Bachelor's degree required, advance degree a plus.
  • 10+ years of experience within a regulatory or pharmaceutical environment with a minimum of 7 years combined relevant experience.
  • Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
  • Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
  • Demonstrated leadership experience that includes the ability to inspire, foster teamwork, and champion change as well as quality decision making.


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.

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