- Business Requirements
- Lean Manufacturing
- Six Sigma Certification
- Analysis Skills
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 an experienced external partner focused Quality Assurance (QA) professional to join us and contribute to our SQM operations as we continue to develop and maintain supplier quality standards to ensure AveXis products are manufactured to relevant patient safety and product quality standards in line with business requirements. This role will provide critical expertise to support areas related to Supplier Quality management, Regulatory CMC, QC Analytics and External Manufacturing (CMO) oversight.
To support the Supplier Quality Manufacturing (SQM) and External Manufacturing department with special focuses on establishing best practices and executing key strategies.
Drive continuous process improvements and developing transparent, risk-based management programs to attain quality goals as pertains to key raw material and product CMOs.
Act as the focal point for directing, escalating and approving key QC analytical investigations (OOS/OOT/Unexpected and Laboratory Deviations) concerning externally manufactured and tested materials and products.
Act as the departmental liaison for supporting Regulatory CMC filing activities with regards to materials controls for raw materials and externally manufactured products, as well as supplier controls.
Provide key support on compliance audit and supplier monitoring for Contract Testing Laboratories (CTL) including participation in business review meetings.
Support leadership on other duties assigned, such as ownership of health authority responses and CAPAs pertaining to SQM.
Bachelor’s Degree required in a scientific discipline.
12-15 years of experience in a Biotech/Pharmaceutical industry, with at least 5 years directly supporting external supplier QA functions.
Certification in 6 Sigma, Lean Manufacturing, Kaizen, PMP, CQA or ASQ is highly desired.
Strong knowledge of laboratory Quality Systems (sample management, testing, laboratory investigations and method qualifications) is required.
Strong Knowledge of GMP (US, EU and APAC), GCP/GLP, as well as ISO standards with regards to material and service providers is required.
Understanding of common biologics and sterile chemical/plastic materials manufacturing processes is strongly preferred
Demonstrated experience designing innovative and complex processes that drive efficiency, compliance and improved values to organization.
Proven planning and prioritizing skills.
Ability to work in a diverse and dynamic environment.
Ability to present data effectively to senior management and external partners.
Good communication and interpersonal skills.
Good listening and negotiation skills.
Good problem-solving and analytical skills.
Ability to travel (approximately 10%).
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.