Senior Director, Quality Assurance

Overview

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. 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 Director, Quality Assurance is responsible for designing and implementing robust Quality Systems for a new viral gene therapy manufacturing site. This person will be responsible for the strategic site quality system design and work in collaboration with Manufacturing Operations to authorize written procedures including but not limited to: monitor and control the manufacturing environment, plant hygiene, process validation, training, raw material suppliers, approval of contract manufacturers, batch release, monitoring and storage conditions of materials and products, document control/record retention, investigations, and monitoring compliance with all requirements of good manufacturing practice.

The Senior Director will be responsible for quality related business systems such as change control, deviation/CAPA, maintenance/calibration, and work orders by contributing and reviewing specifications and user requirements, assisting with the implementation and supporting on-going improvements. This role will be responsible for assembling and hiring a collaborative and high-performing Quality team to ensure the quality systems are implemented and sustained. The Senior Director will provide critical quality 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 multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international).

Responsibilities

• Develop and deliver a robust overall quality systems, strategy, and ultimate plan resulting in a fully compliant facility with respect to procedures and processes.
• Create and lead monthly Quality Management Review meeting (QMR) attended by senior leadership to review plant metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.
• 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).
• Responsible for hiring high-performing quality team to ensure robust quality systems are implemented and sustained including:
• SOPs/Document Management: Approve all instruction sets, specifications, sampling instructions, test methods etc. and other Quality control procedures directly related to 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 Qualification/Raw Material Release: Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product
• QC Testing/Batch Release: Manage QC lab (including introducing new method qualifications, as appropriate) and all batch release activities to ensure compliant and timely product disposition
• 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
• Validation/Maintenance: Ensure appropriate maintenance and a state of qualification is maintained for equipment and facilities in area of responsibility
• Participate in external vendor quality audit program. Manage findings, responses and corrections plus lead investigations that involve any raw materials required to manufacture the product.
• Manage site inspection preparation, management and response process.
• Selection of manufacturing, testing, and distribution contract suppliers (support audits as needed).
• Provide quality input during manufacturing runs at CMOs.
• Ensure all stability studies are designed and executed to enable IND and BLA filings.
• Successfully design and approve material compatibility experiments of finished goods components.

Qualifications

• Minimum B.S. degree in preferably microbiology, chemistry or biochemistry.
• A minimum of 8-10 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification, aseptic fill/finish, testing of drug substance and drug product. Experience with viral gene therapies and/or orphan disease indications is a plus.
• 5+ years of direct supervisory experience of technical professionals with demonstrated effectiveness to recruit, hire and train a team as well as provide continued uidance, mentorship and support to staff.
• Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.
• Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product related investigations and deviations.
• Excellent oral and written communication skills with strong technical writing experience required.
• Experience leading both internal and external vendor 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.