Quality Program Manager - CAPA, Non Conformance & Complaints Program

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Company: Personalis

Location: Fremont, CA 94536

Description:

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:
As a key member of the Quality Assurance & Regulatory Compliance team, the Quality Program Manager will play a critical role in the implementation and enhancement of the Personalis Quality Management System (QMS). This role focuses on ensuring that the Corrective and Preventive Actions (CAPA), non-conformance, and complaints processes are effectively managed and continuously improved, in strict alignment with ISO 13485:2016 and 21 CFR 820 regulatory standards.

The ideal candidate brings extensive experience in managing CAPAs, non-conformances, and complaints within regulated environments, particularly under ISO 13485 and 21 CFR 820 frameworks. This role demands a proactive approach with minimal supervision, reporting directly to the Director of Quality Assurance.

Hybrid: Monday and Tuesday onsite in Fremont. Additional days as needed.

Key Responsibilities:
  • Lead the implementation and ongoing enhancement of the QMS, ensuring full compliance with internal procedures and external regulatory requirements, with a focus on ISO 13485:2016 and 21 CFR 820.
  • Take ownership of the CAPA, Nonconforming (NC), Plan Deviation (PD), Complaints, and Medical Device Reporting (MDR) programs, ensuring they meet all regulatory and company standards.
  • Conduct gap assessments for CAPA, NC, PD, Complaints, and MDR procedures, implementing corrective actions based on assessment results.
  • Work closely with Clinical Laboratory, Operations, Development, and other cross-functional teams to gather and synthesize relevant data for CAPAs, NCs, PDs, and Complaints.
  • Lead the CAPA Board, ensuring timely closure of CAPAs.
  • Oversee the creation, implementation, and maintenance of Standard Operating Procedures (SOPs) and other QMS documentation.
  • Provide day-to-day support for QMS-related inquiries or issues, partnering in troubleshooting and investigations to ensure comprehensive and timely resolution.
  • Provide support during internal and external inspections and inquiries from regulators such as FDA and ISO, CLIA, CAP.
  • Other responsibilities assigned by the reporting manager.


Qualifications:
  • Bachelor's degree in a scientific or technical discipline, or a related field, is required.
  • Minimum of 8 years of experience in Quality Systems within the biotechnology, medical device, or pharmaceutical industries.
  • Proven experience in implementing and managing electronic Quality Management Systems (QMS).
  • In-depth knowledge of relevant US and global compliance regulations and industry standards.
  • Extensive experience in maintaining and enhancing ISO 13485 and 21 CFR 820 Quality Management Systems.
  • ISO 13485:2016 Lead Auditor certification is highly desirable.
  • Proficient in ISO 14971 Risk Management standards.
  • Strong experience in preparing for and participating in regulatory inspections.
  • Strong ability to critically evaluate, troubleshoot, and resolve complex issues with attention to detail.
  • Excellent ability to manage multiple priorities and meet agreed upon timelines.


The hiring range for this position is $125,000 to $155,000 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 contacts you.

Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package and benefits including medical, dental, vision, 401(k) match, ESPP, tuition reimbursement, sick/vacation time, commuter benefits/ EV charging stations, onsite gym, and wellness benefits. (For US only, benefits in other countries may vary.)

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