Associate Director, Global Quality Systems

Compensation

: $92,940.00 - $149,980.00 /year *

Employment Type

: Full-Time

Industry

: Executive Management



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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 Associate Director, Quality Systems 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 global quality system design and work in collaboration with AveXis sites to develop multi-site and global procedures in accordance with Novartis Quality Modules.

Responsibilities

  • Support activities related to maintaining AveXis' quality system infrastructure and ensure alignment with Novartis Quality Modules, Global Standards and processes
  • Drive key QMS initiatives from development through successful implementation throughout the organization
  • Contribute to QMS Governance by further strengthening Global Quality System concept and supporting Quality Systems leads
  • Act as liason between Global Quality Systems team and different business units (Drug Development, Pharmacovigilance, Regulatory, etc.) to ensure alignment
  • Drive key strategic/simplification initiatives taking into consideration business needs, critical success factors and planned timelines including communication and roll-out
  • Continuously improve and streamline QMS processes by e.g. developing new tools, removing non-value adding activities, automating manual steps
  • Act as a QMS representative/SME and liaison partner in other initiatives and projects


Qualifications

  • Minimum B.S. degree preferably in microbiology, chemistry or biochemistry.
  • A minimum of 10-12 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.
  • 7+ years of direct supervisory experience of technical professionals with demonstrated effectiveness to recruit and train a team as well as provide continued guidance, 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.
  • Strong knowledge and application of the CFRs and cGMPs and involvement in multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international).
  • Excellent oral and written communication skills with strong technical writing experience.
  • Experience leading both internal and external vendor audits, identifying findings, driving resolution and providing closure report.
  • Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
  • Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence.
  • Approximately 25% 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.
Associated topics: administrative assistant, administrative staff, assistant, asso, beverage, chief operations officer, front office, operational assistant, operational support, records management * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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