At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California.
Summary: The Director, Quality Assurance (QA) will be an integral part of the Personalis Quality Regulatory and Clinical Compliance (QRC) leadership team and will be responsible for providing QA leadership and oversight of Personalis's Quality Management System with focus on CAPA, Nonconformance, Complaints, Adverse Events, Supplier Quality, and Incoming Inspections. This role is key to ensure compliance with FDA 21 CFR 820, ISO 13485, CLIA, State of California, CAP and NYS requirements. This position reports to the VP Quality Assurance, Regulatory Compliance & Clinical Laboratory. This is a hybrid position based in the Bay Area, California, and requires the individual to work on-site at the Personalis office in Fremont at least two days per week or as per company policy.
Responsibilities: Drive the organization towards ongoing conformance with ISO 13485:2016 and FDA 21 CFR 820 with special oversight of CAPA, Non Conformance, Complaints, Adverse Events, Supplier quality and Incoming inspections.Take a leadership role in quality and regulatory initiatives including pharma co-development programs for clinical trial assay (CTA), IDE, 510(k), De Novo, PMA, and IVDR related submissions.Lead efforts for continuous refinement of processes and QA strategies to ensure compliance with ISO, FDA, IVDR, CLIA, CAP, NY etc.Lead quality improvement activities as appropriate to raise the performance and quality of the organization's process outcomes and offered products.Author, review and approve documentation (SOPs, protocols, technical reports, specifications, Batch Records etc.).Ensure timely execution of Internal Audits and Management Reviews and follow up on Inspections and Audits in relation to eventual findings responses and remediation efforts.Support timely application/ re-application for licensure and accreditation documents submission.Supervise, guide and manage hired or assigned quality sub-systems managers and specialists as applicable.Supervise the review of protocols, analytical results, and documents associated with investigations and corrective and preventive action (CAPA) plans.Lead and proactively participate in the internal audits process and second-party audits, track its progress, and trend results, and assure proper documentation of findings.Lead and proactively participate in the conduct of supplier audits, specifically by monitoring vendor performance and establish criteria and rating system for critical vendors.Supervise the execution of root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements.Participate in improving the process of the statistical collection of data to predict trends that will affect improvement of product quality.Interface with customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.Establish operational objectives, assignments and delegate to broader team and/or sub teams.Relate to others in a way that fosters collaboration, values diversity and enables effective work relationships.Make clear decisions, remove obstacles, and provide resources to the Quality Assurance team.Drive additional tasks and assignments, as needed.Requirements: Minimum education required: BS/MS in a scientific discipline.Minimum experience required: 10+ years' of experience in FDA 21 CFR 820 regulation and ISO standards (ISO 13485), IVDR.Proven experience with FDA and Notified Body (ISO 13485:2016) Inspections.Experience in IVD submissions with FDA (IDE, 510(k), De Novo, PMA etc) and EU (IVDR) highly desirable.Proven experience in leading implementation of or optimization of Quality Management System.Proven experience in leading deviation investigations, determining root cause, and developing corrective action plans.Auditor (ISO or CAP) Certification highly desirable.Experience with design control and document control systems.Excellent and proficient communication skills and ability to effectively articulate messaging and purpose to partner with other parts of our organization.Experience authoring, reviewing and approving (SOPs, protocols, reports, batch records, etc.).Proficiency with enterprise systems, i.e., documentation, LIMS (analytical data management), LMS (learning management systems), deviations, CAPA, etc.Detail oriented, thoroughness and accurate in performing assigned tasks.Proven ability to use multiple software tools.Understanding and knowledge of statistical methods applied to QA systems preferred.Overall technical and scientific understanding of clinical diagnostics in relation to genetic / genomic testing highly desirable.The hiring range for this position is $190,000 to $230,000 per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.
Personalis is an equal opportunity employer and is committed to the full inclusion of all individuals. As part of this commitment, Personalis will ensure that persons with disabilities are provided with reasonable accommodations. If you need an accommodation to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please let your recruiter know, if/when they contact you.
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