At 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 canât wait to talk to you!
About the Role:
Reporting 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 statusâs and disposition of materials across all programs within 270âs ERP system, Oracle. The primary responsibility is assuring compliance to procedures guiding the maintenance/movement of materials within 270âs ERP system. This role will also support Supplier Management and/or internal compliance through auditing.
What you’ll do:
- Provide GXP labeling and packaging compliance expertise to teams, ensuring all labeling, packaging and traceability operations comply with all applicable regulations and guidelines
Partner 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
â¢ Collaborate with Supply Chain team, ensuring consistent GXP compliance & quality system functionality in supply chain operations around material movements and/or material status
â¢ Serve as Quality contact for Supply Chain related quality events and issues, including deviations, investigations, CAPA and change controls ensuring timely closure
- Support both internal and external audit program as needed
Provide Quality oversight for Supply Chain in Quality documentation – from development to approval
â¢ Ability to identify quality issues and effectively and proactively communicate and resolve them in a diplomatic, flexible, and constructive manner
â¢ Develop, implement and improve Quality processes which are scalable and sustainable to meet the organization’s growing needs
â¢ Participate and/or lead root cause analysis, Risk Assessments and CAPA effectiveness check, as needed
â¢ Engage in activities to continuously assess and improve supply chain quality processes.
â¢ Support the development, implementation, and revision of applicable supply chain quality processes in corporate quality systems.
What you’ll bring:
- BA/ BS and a minimum of 5+ years in Quality Assurance
- Demonstrated leadership abilities
- Ability to demonstrate effective work prioritization skills
- Ability to receive and process large quantities of information, to make concise and timely decisions
- Experience with product lot disposition, investigations, change control, and process qualification and validation
- Knowledge of ERP system and/or Supply Chain operations (Shipping, storage, materials, supplier)
- Ability to communicate above and below level in a way that fosters positive relationship building
- Strong knowledge of GxP regulations, quality systems, and guidance documents
- Experience with managing contract manufacturing and contract testing organizations would be beneficial in this role.
- Demonstrates flexibility and excels within a fast-paced environment with changing priorities.
- Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
- Must have excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities with aggressive timelines
- Ability to travel approximately 10%
- Opportunity to be location flexible – Cambridge or remote
- Auditor Certification is desired