ARE YOU ADAPTIVE? We’re driving groundbreaking research in cancer and other immune-mediated diseases that translates into novel clinical diagnostics and innovative therapeutics. We are at the forefront of immune-based discoveries, transforming the future state of health through our disruptive, proprietary immunosequencing technology. With strong financial footing and rapid growth, we are looking for the brightest, most passionate and collaborative innovators to join us.
At Adaptive, you'll be challenged, you'll be inspired, and you'll be proud to be part of an innovative organization making a real impact on improving the quality of life globally. No matter what your role is, you'll find a diverse, team-driven, fun culture where your contributions truly count. #BeingAdaptive
This position is responsible for establishing and maintaining the Quality System at the Seattle, WA headquarters of Adaptive Biotechnologies. This role provides assurance over internal activities as well as quality oversight of third-party contract manufacturers (CMOs), suppliers, and service providers. This position participates and provides quality and compliance leadership in the design, establishment and maintenance of programs and processes that ensure quality products and services, in compliance with US and International quality systems regulations for IVD products and CLIA-regulated services.
Duties and Responsibilities
- Author, edit, review, and approve policies, SOPs, and guidance documents in compliance with global regulatory requirements, including 21CFR820, ISO13485, CLIA88, ISO14971.
- Manage and administer Quality Assurance, Software QA and Supplier Quality processes within the Quality System.
- Review manufacturing and testing documentation including validation/qualification, batch records, and other technical documents. Support final review and release of material produced in-house and at contract manufacturers.
- Support compliance audits (GMP, GLP, GCP, Internal and Supplier/External).
- Provide Quality oversight for the labeling, packaging, storage, and distribution of clinical trial materials.
- Collaborate with functional groups and contract manufacturers to evaluate and address complex issues such as deviations, complaints, corrective and preventive action (CAPA) and failure investigations. May lead or coordinate investigations and corrective and preventive action (CAPA) recommendations related to products.
- Serves as a Quality representative on one or more new product development project teams.
- Responsible for design history file management and review and approval of associated documents.
- Provides input into strategic goals and identifies and elevates gaps in current goals.