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.
The Quality Assurance Associate is responsible for implementing and maintaining robust Quality Systems for a new viral gene therapy manufacturing site. This person will be responsible for the strategic compliance to written procedures including but not limited to: regulatory adherence and audit support, raw material qualification, specifications, supplier management, internal assessment processes, quality management review, annual product quality review (APQR), incoming release of materials and monitoring compliance with all requirements of good manufacturing practice.
The Quality Assurance Associate will provide expertise to transition a novel gene therapy into a commercially approved product. This individual must have a strong knowledge and application of the CFR’s and cGMP’s. Experience with regulatory inspections, self inspections, and external audits is a plus.
Provide strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQA’s) and critical processing parameters (CPP’s).
SOPs/Document Management: Approve all instruction sets, specifications, instructions and other Quality Assurance procedures directly related to incoming quality /operations and other cGMP activities.
Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause.
Vendor Management/Raw 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.
Responsible for handling of complaints at the site level.
Participate in self inspection program for the manufacturing facility. Manage findings, responses and corrections.
Responsible for data integrity review of electronic raw data against the reported data as needed to support raw material releases.
Participate in Site inspection preparation and response process for regulatory agencies.
Coordinate completion of Annual Product Quality Review (APQR) reports for the marketed products
Create monthly Quality Management Review meeting (QMR) to review site metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.
Minimum B.S. degree in preferably microbiology, chemistry or biochemistry.
A minimum of 3-5 years of experience in biopharmaceutical based GMP manufacturing operations is preferred.
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.
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.
Approximately 10% 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.