Manager, Supplier Pharmacovigilance Quality Assurance (Elk Grove Village)
Employment Type: Full-Time
Industry: Non-Executive Management
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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 Manager, Supplier Pharmacovigilance Quality Assurance (PV QA) is responsible for activities overseeing the quality of suppliers that are part of the AveXis Pharmacovigilance(PV) System. In this role, Manager of Supplier PV QA will be responsible for decision-making regarding quality assurance topics relating to suppliers used across AveXis and ensuring quality and compliance to the AveXis Pharmacovigilance system requirements. This role will work directly with the Supplier Quality Assurance organization and the Global Patient Safety organization to ensure all required PV suppliers are properly qualified and documented as part of the AveXis PV system.
A successful candidate will provide critical strategic quality expertise to transition a novel gene therapy into a commercially approved product. This individual must have a strong knowledge and application of the global pharmacovigilance regulations and have been involved in multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international). Responsibilities
- Provide direct PV Subject Matter Expertise to the AveXis Supplier Quality Assurance organization in the classification and qualification of PV suppliers at AveXis.
- Support risk assessments of new suppliers and give guidance on the impact of the suppliers on the AveXis PV system.
- Support desktop and potentially onsite qualification, routine or for cause audits of suppliers deemed critical to the AveXis PV system.
- Oversees quality and compliance of PV suppliers including case processing vendors and other Tier 1 GVP suppliers.
- Ensure all AveXis suppliers with impact on the AveXis PV system are tracked and managed in a compliant manner.
- Manage site inspection preparation, management and response process.
- Coordinate and implement the roll out of global quality commitments and initiatives across the PV system.
- Serve as the quality lead to support supplier risk assessments, supporting the identification of quality risks and appropriate mitigation plans to achieve compliant solutions.
- Identify and drive continuous improvement and standard practices for Quality to achieve both top performance and consistency, where appropriate, across the AveXis pharmacovigilance system.
- Support and approve the investigation and CAPAs for regulatory non-conformances / deviations involving to AveXis suppliers.
- Support development of the AveXis supplier qualification and audits systems by providing direct SME domain experience to the Supplier QA and QA Compliance teams.
- Collaborate with Clinical Quality and Global Quality in the development of global quality standards at AveXis.
- Lead the development and update of SOPs and work instructions.
- Bachelors and/or Masters/PhD/PharmD degree in a life sciences or scientific discipline.
- 5-7 years of experience working within the patient safety/ pharmacovigilance domain including quality, compliance, operations or medical safety experience.
- At least 3 years of experience in a Quality function.
- Experience in supporting Commercial, Medical and Regulatory suppliers that are part of the PV system.
- Comprehensive knowledge of FDA and EMA pharmacovigilance regulations for products in a clinical development or post-marketed setting.
- Experience in US and international regulatory agency inspections.
- Strong project management skills and ability to communicate effectively across matrix functions at all levels of the organization, influencing areas not under direct control to achieve shared objectives while balancing speed, quality and risk.
- Credible knowledge of global regulations governing Pharmacovigilance for products in clinical development and post-marketing.
- Proficient MS Office and SharePoint skills.
Up to 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.
Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task
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