Quality Assurance and Compliance Specialist (Multiple Openings)

Employer
AveXis Inc.
Location
San Diego, CA, US
Posted
Sep 28, 2019
Ref
2019-4131
Hotbed
Biotech Beach
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 highly motivated and solution-driven Quality Assurance and Compliance Specialist to join the dynamic and growing Quality Assurance (QA) team at our site. The individual will collaborate closely with Quality Control (QC) to support compliance oversight for qualification, validation and transfer and routine review of bioassay methods. The individual should possess strong understanding of QC testing operations and provide QA oversight expertise in several QC assays, such as cell-based potency assay. In this role, the individual is expected to work independently on quality oversight for lab investigations and CAPA.

Responsibilities

  • Responsible for supporting the development and implementation of robust quality systems including:
    • SOPs/Document Management: Approve all instruction sets, specifications, instructions and other Quality Assurance procedures directly related to operations and other cGMP activities.
    • 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.
  • Oversight of testing operations in the QC laboratory and participate as a QA subject matter expert for QC analytical assays performed in San Diego QC Lab.
  • Responsible for data integrity review of electronic raw data against reported data.
  • Participate in site inspection preparation, management and response process.


Qualifications

  • Minimum B.A. or B.S. in biochemistry or related scientific field.
  • A minimum of 5 years of experience in biopharmaceutical based GMP operations. Experience with viral gene therapies and/or orphan disease indications is a plus
  • Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections, preferred.
  • 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.
  • Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.


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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