Senior Quality Assurance Engineer (ACO)

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, 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 Senior Quality Assurance Engineer is responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at the AveXis new gene therapy manufacturing site. The Quality Assurance Engineer 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 and have been involved in regulatory inspections. Full audit support of all internal and external audits in support of the product manufacture and launch.

Responsibilities

• Responsible for the Quality and Compliance aspects of design and work in collaboration with Engineering, technical functions, Manufacturing Operations and outside consultants and contractors to ensure that AveXis facility is:
  • Compliant with all appropriate regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing
  • Capable of manufacturing AveXis products that are safe, effective and that meet all applied controls and specifications
  • Capable to meet intended design goals of output volume, turnaround time and operating and product costs.

• Provide strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters)
• Contribute to the definition of project plan, control requirements and processes to deliver the new manufacturing facility on time, to required quality and compliance standards, within budget.
• Contributing to design of facility, utilities and process equipment from a Quality and Compliance perspective.
• Identify resource requirements to support the plan, procure resources (internally, or externally). May hire and supervise external staff.
• Act as Quality approver on project deliverables, as defined in the project plan.
• Work with AveXis validation colleagues to define the initial asset life-cycle model and qualification and validation strategy, to ensure successful validation of the facility. Play a lead role in the planning, execution and closure of commissioning, qualification and validation activities from a Quality functional perspective.
• Author and/or approve Standard Operating Procedures in support of project activity and deliverables.
• Provide QA oversight of engineering, validation, and facilities activities related to maintaining a GMP facility in a validated state.
• Act as the Quality approver of change controls, deviations, and CAPAs required to maintain the manufacturing facility in a GMP state.
• Work with AveXis supplier and Vendor Management colleagues to ensure that suppliers of goods and services for the new manufacturing facility are compliant and capable of fulfilling their contracted requirements. Participate in external vendor quality audit program for the manufacturing facility. Manage findings, responses and corrections plus lead investigations for critical issues.
• Training: Ensure all quality 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

Qualifications

• Minimum B.S. degree in preferably engineering, chemistry or biochemistry.
• A minimum of 5-8 years of experience in biopharmaceutical based GMP manufacturing operations.
• Experience with viral gene therapies, cell culture technologies 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 with commissioning, qualification and validation to meet FDA and other health authority requirements.
• Experience with deviations, CAPAs, and Change Controls.
• 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, identify findings, drive resolution and provide closure report.
• Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.
• Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence.
• Approximately 20% 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. #LI-MG1