The Senior Staff Quality Engineer will act as a key liaison from quality with both the internal MSAT Manufacturing operations as well as with external Contract Manufacturing Organizations (CMOs). This individual will be responsible forCurrent Good Manufacturing Practices (cGMPs), GCP, ISO 13485.2016, FDA, CLOIA, CAP, and New York State are implemented and tech manufacturing transfer to RTP (North Carolina Site). Additional Support for manufacturing batch records, IR's, Material Management, specification development, validation support, CAPA'S and Quality Systems and Audit support. This position is required to be onsite at Menlo Park, California.
* Have quality oversight of contract manufacturing operations for both commercial and clinical trial materials. Includes review and approval and change control requests, deviations, and investigations.
* Lead material management meetings and track non-conformance investigations with operations and supply chain for Menlo Park
* Ensure all nonconforming/IR's for materials/reagents are accurately controlled and dispositioned in LIMS/NetSuite.
* Own and manage Alternative Materials Program
* Ensure timely closures of non-conformances (IR's) and CAPA'S related to operations and QC.
* Procedure development: Review/Write procedures as the need arises for the QMS related to operations, equipment, material management etc.
* Develop , implement , and conduct a Quality operations training program (Receiving inspection, Sampling, methodology, investigation, etc)
* Attend all material management meetings, including MRC and be singe point of contact for materials related issue s.
* Batch records previews/ approvals/ changes on site at Menlo Park
* Change Control support as the need arises (reviews and approvals)
* Process Improvements and Validation support for RTP and Menlo Park.
*Equipment and Facility failures investigations and material impact/containment (Menlo Park)
* Oversee and supervise Quality processes to ensure operations and adequately defined and that GMPs are utilized for the manufacture of reagents internally and at CMOs.
* Review and guide process validation and test method validation plans and protocols, executed protocols, and summary reports for both GRAIL and CMOs.
* Performs technical assessments and quality approval of deviations, incident reports, nonconformances, CAPAs and investigations for commercial and clinical products.
* Participate in risk assessment and / or Failure Mode and Effects nalysis activities for both process and mfg. FMEAs.
* Define and implement, as appropriate, quality standards, systems, and metrics for commercial operations.
* Compile, coordinate, and present metrics for areas of responsibility to senior management.
* Participate in preparation for and execution of internal or external audits. Ensures audit observations are addressed appropriately and completed on schedule.
* Manage review of product release and data, Quality lead for method transfers and validations.
* Support Quality Management Reviews and periodic product reviews.
* Support the development, implementation, and revision of corporate quality systems.
* Participate in continuous improvement strategy which aligns to the business strategy and operational strategy while taking into account present operational realities.
* Set Operational metrics an drive improvements into IR's, SCAR's, CAPA's, and Change Controls as needed
* Batch record process ownership and compliance.
*BA/BS and a minimum of 10 years in Quality Assurance
* Chemistry background preferred.
* Minimum of 7 hears in Quality Operations at FDA-regulated medical device or pharmaceutical company
* Minimum of 5 years of project management experience preferred
* IVD experience (reagents and assays) preferred
* Method validation and process validation.
* Proven experience in Change Control, CAPA's, CMO management, and technology transfer.
* Demonstrated success engaging teams and partners for collaboration in advancing quality operations and outcomes in business and quality leadership.
* Experience with managing contract manufacturing and/ or testing organizations, including quality agreement negotiation.
* Ability to intake and process large quantities of information and subsequently make concise and timely. decisions.
* Ability to communicate above and below level in a way that fosters positive relationship building.
* Proven knowledge of GxP regulations, quality systems, and regulatory guidance documents in the US and EU
* Demonstrated flexibility and advancement within a fast-paced environment.
* Demonstrated project management skills.
* Ability to work effectively in a collaborative team environment where results are achieved through Influence and incorporating multiple points of view.
* Excellent attention to detail, project and time management skills, andthe ability to manage multiple competing priorities.
* Ability to travel 25% of the time.
Additional Salary Information: 17% annual bonus and Restricted Stock Units
Internal Number: 1156
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.