2seventy bio, Inc is hiring a Remote Quality Associate External Manufacturing Supply Chain Quality Assurance Oncology
\nAt 2seventy bio, we are excited to continue leading the charge on Oncology cell therapy research. We combine our real-world clinical data from our approved multiple myeloma treatment with our tool kit of several cutting-edge technologies, dedicated partners, passionate innovators that care, and our unwavering dedication to important life-changing work. We strive to make a difference and offer more time for patients with cancer. We show up daily for our patients (literally and figuratively) and we feel privileged to be a part of their journey. If you want to challenge the status quo while having fun doing so, come be a part of this unique and exciting opportunity - we canโt wait to talk to you!\n\nAbout the Role:\n\nReporting to the Associate Director, Supply Chain Quality, this role is responsible for Quality support in the areas of supply chain. The Quality Associate, External Manufacturing/Supply Chain, supports the Oncology organization by having responsibility for material movements, maintenance of material statusโs and disposition of materials across all programs within 270โs ERP system, Oracle. The primary responsibility is assuring compliance to procedures guiding the maintenance/movement of materials within 270โs ERP system. This role will also support Supplier Management and/or internal compliance through auditing.\n\nWhat you'll do:\n\n\n* Provide GXP labeling and packaging compliance expertise to teams, ensuring all labeling, packaging and traceability operations comply with all applicable regulations and guidelines\nPartner with Enterprise Resource Planning (ERP) and Material Data Management (MOM) teams providing quality approval of items and products within ERP that support supply chain needs, ensuring alignment with GXP requirements and internal processes\nโข Collaborate with Supply Chain team, ensuring consistent GXP compliance & quality system functionality in supply chain operations around material movements and/or material status\nโข Serve as Quality contact for Supply Chain related quality events and issues, including deviations, investigations, CAPA and change controls ensuring timely closure\n\n* Support both internal and external audit program as needed\nProvide Quality oversight for Supply Chain in Quality documentation - from development to approval\nโข Ability to identify quality issues and effectively and proactively communicate and resolve them in a diplomatic, flexible, and constructive manner\nโข Develop, implement and improve Quality processes which are scalable and sustainable to meet the organization's growing needs\nโข Participate and/or lead root cause analysis, Risk Assessments and CAPA effectiveness check, as needed\nโข Engage in activities to continuously assess and improve supply chain quality processes.\nโข Support the development, implementation, and revision of applicable supply chain quality processes in corporate quality systems.\n\n\n\n\nWhat you'll bring:\n\n\n* BA/ BS and a minimum of 5+ years in Quality Assurance\n\n* Demonstrated leadership abilities\n\n* Ability to demonstrate effective work prioritization skills\n\n* Ability to receive and process large quantities of information, to make concise and timely decisions\n\n* Experience with product lot disposition, investigations, change control, and process qualification and validation\n\n* Knowledge of ERP system and/or Supply Chain operations (Shipping, storage, materials, supplier)\n\n* Ability to communicate above and below level in a way that fosters positive relationship building\n\n* Strong knowledge of GxP regulations, quality systems, and guidance documents\n\n* Experience with managing contract manufacturing and contract testing organizations would be beneficial in this role.\n\n* Demonstrates flexibility and excels within a fast-paced environment with changing priorities.\n\n* Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view\n\n* Must have excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities with aggressive timelines\n\n* Ability to travel approximately 10%\n\n* Opportunity to be location flexible - Cambridge or remote\n\n* Auditor Certification is desired\n\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Travel and Travel jobs that are similar:\n\n
$70,000 — $100,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nCambridge, Massachusetts, United States
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