Senior Manager, Quality Assurance
1 month ago
Arsenal Biosciences Inc. is a pioneering clinical stage programmable cell therapy company dedicated to engineering advanced CAR T-cell therapies for solid tumors. Our mission is to defeat cancer through innovative and computationally driven approaches.
Job SummaryWe are seeking a highly experienced and skilled Senior Manager, Quality Control to join our Technical Operations Quality team. The successful candidate will provide technical expertise and leadership in overseeing QC/Analytics and clinical product testing of cell therapy products.
Key Responsibilities- Establish and implement a comprehensive QC strategy for the organization, ensuring timely and accurate release of cell therapy drug products.
- Make sound decisions regarding complex technical issues and communicate effectively with internal stakeholders.
- Provide technical guidance and support to team members, contractors, and consultants as needed.
- Collaborate with Quality Operations, Process Development, Analytical Development, and Manufacturing to ensure the success of our clinical scale manufacturing process.
- Provide support for deviations, OOS, change control, investigations, and CAPA, as well as during inspections/audits as a QC subject matter expert.
- Contribute to regulatory submissions (IND/BLA) and establish team priorities to meet overall project targets and timelines.
- Bachelor's degree in a relevant scientific field or discipline, with 10+ years of experience in the biotechnology/pharmaceutical industry, advanced degree preferred.
- 4+ years of progressive management experience and proven leadership skills managing a quality control function.
- Strong knowledge of cGMP/ICH/FDA/EMA regulations and prior experience in Quality/Analytics for cell therapy products.
- Ability to work in cleanroom environments and prioritize deliverables for the overall good of the project.
ArsenalBio offers a comprehensive benefits package, including medical, dental, and vision, as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave, and health savings accounts. We also offer flexible work schedules and flexible time off, including two extra 'Arsenal Days of Rest' every quarter for employees to recharge.
We are committed to hiring the best talent from diverse backgrounds and believe in investing in the well-being of our employees. If you are a motivated and experienced leader looking to join a dynamic team, please submit your application.
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