Manager, Manufacturing Quality

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
Aug 20, 2019
Ref
2019-4063
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.

The Manufacturing Quality Manager will provide critical quality expertise to transition a novel gene therapy into a commercially approved product and is responsible for implementing robust Quality Systems for a new viral gene therapy manufacturing site and being quality on the manufacturing floor.

Responsibilities

  • Deliver robust overall quality systems, strategy, and ultimate plan resulting in a fully compliant facility with respect to procedures and processes.
  • Drive and manage quality decision making on the manufacturing floor.
  • SOP/Document Management: Approve all instruction sets, specifications, batch records and other Quality procedures directly related to manufacturing operations and other cGMP activities.
  • On the floor batch record review:
    • Set culture and expectations for real time quality review of controlled documentation during processing for GMP and GDP.
    • Collaborate intensively with manufacturing operations to develop best in class workflows and processes to support high quality, risk assessed, GMP operations.
  • Deviation/CAPA Management approval: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause. Requires direct input on the creation and effectiveness of Corrective and Preventive Action plans. Assist with implementation and supporting on-going continuous improvements.
  • 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.
  • Supervise Manufacturing Quality Associates by:
    • Providing work direction, performance management and professional development.
    • Develop Manufacturing QA shift support strategy which mirrors Manufacturing Operations.
    • Hire best in class team.


Qualifications

  • Minimum B.S. degree preferably in microbiology, chemistry or biochemistry.
  • A minimum of 5 years' experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification and aseptic fill/finish.
  • Experience with viral gene therapies and/or orphan disease indications is a plus.
  • Comprehensive knowledge of FDA and EMA 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 reports.
  • Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
  • Knowledge of AQLs and visual inspection.
  • Strong knowledge and application of the CFR's and cGMP's.


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.