Sr. Manager / Associate Director, Quality Audits
Personalis, IncFremont, California, United States · Posted 1 month agoDescription
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 Senior Manager / Associate Director, Quality Systems & Audits is a high-level leadership role within the Quality Assurance department. Reporting directly to the Director of Quality Assurance, this individual is responsible for the strategic oversight, design, and execution of the global Internal Audit program, as well as leading the readiness and management of all External Audits (including regulatory inspections and accreditation assessments).
The successful candidate will have strong leadership skills and possess extensive experience managing Quality Management Systems (QMS) within highly regulated environments, driving compliance, governance, and continuous improvement across the organization with a high degree of autonomy.
Onsite: Monday, Tuesday, and an additional day
Key Responsibilities:
Audit Program Leadership & Governance
- Strategic Oversight: Establish, maintain, and oversee the strategic vision for the corporate Internal Audit program and external audit readiness frameworks to ensure compliance with CLIA, CAP, ISO 13485, 21 CFR 820, IVDR, and GCP and GCLP.
- Audit Lifecycle Management: Oversee and execute the end-to-end audit lifecycle, including the definition of corporate audit programs, master scheduling, resource planning, and formal scoping of complex quality system projects.
- Executive Reporting: Author, review, and finalize high-level audit reports and compliance metrics. Present comprehensive monthly trend reports, performance metrics, and status updates directly to executive leadership for Management Review.
- Regulatory & Licensure Support: Lead external regulatory inspections and support the preparation and submission of crucial documentation for licensure and accreditation.
Cross-Functional Collaboration & CAPA Management
- Stakeholder Engagement: Actively partner with department heads and process owners to communicate audit results, evaluate systemic findings, and collaboratively resolve complex, audit-related compliance issues.
- Root Cause & Investigation Leadership: Provide expert guidance and lead cross-functional investigation teams in executing comprehensive root cause analyses for CAPAs, deviations, and non-conformances stemming from internal and external audits.
- Continuous Improvement: Champion continuous improvement initiatives across all Quality Systems, leveraging audit insights to drive operational excellence and robust process controls.
Team Mentorship & Professional Development
- Staff Coaching: Provide strategic direction, advanced training, and mentorship to internal staff to elevate the organization's audit capabilities and regulatory posture.
- Resource Coordination: Supervise the coordination of process owners and supporting documentation to ensure absolute preparedness for all internal and external evaluation windows.
Education and Experience:
- Education: Bachelor’s degree in a scientific, engineering, or related discipline. Advanced degree or professional audit certifications (e.g., ASQ CQA, Lead Auditor certification) highly preferred.
- Experience: A minimum of 8–10 years of progressive experience in a Quality Assurance role within an FDA-regulated or ISO-certified medical device, IVD, or clinical laboratory environment (with at least 5 years operating at a senior specialist, project management, or leadership level).
- Regulatory Expertise: Deep, expert-level knowledge of ISO 13485, 21 CFR 820, ICH E6 (R3) Guidance for GCP , GCLP, CLIA, and CAP regulations.
- Methodological Mastery: Proven expertise in quality system methodologies, including CAPA management, Lean principles, 5 Whys, and Pareto Analysis.
- Technical Skills: Advanced proficiency in data compilation, metric synthesis, corporate SOP authorship, and the use of electronic document management systems (EDMS) alongside standard office suites (Word, Excel, PowerPoint).
- Leadership & Communication: Exceptional written, verbal, and interpersonal communication skills, with a proven track record of leading high-energy, demanding cross-functional initiatives with minimal supervision.
The hiring range for this position is $165,000 to $210,000 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.
Protecting Our Candidates: At Personalis, we value your security. Please note that all official correspondence from our team will come exclusively from @personalis.com email addresses. We will never ask for personal financial information or conduct interviews over text or chat platforms. If you receive a suspicious request, it is likely a scam. We are committed to a safe recruitment experience and actively work with authorities to investigate and prosecute cyber crimes targeting our community.
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.)
#LI-KK1 #LI-Hybrid
Similar jobs
Est. 162,500 USD
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…
Est. 120,500 USD
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…
Est. 150,000 USD
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…
Est. 69,450 USD
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…
Est. 124,800 USD
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…
Est. 181,440 USD
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…
Est. 100,000 USD
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…
Est. 100,000 USD
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…
Est. 254,000 USD
Position Summary: The Senior Director, Companion Diagnostics (sitting onsite in Frederick, MD) will be responsible for overseeing the laboratory activities for teams focused on supporting both commercially approved CDx s…
Est. 254,000 USD
Position Summary: The Senior Director, Companion Diagnostics (sitting onsite in Frederick, MD) will be responsible for overseeing the laboratory activities for teams focused on supporting both commercially approved CDx s…
Est. 254,000 USD
Position Summary: The Executive Director / Site Head of Precision for Medicine (located onsite in Frederick, MD) will be responsible to oversee the laboratory operations across 3 different functional groups in Frederick,…
Est. 254,000 USD
Position Summary: The Executive Director / Site Head of Precision for Medicine (located onsite in Frederick, MD) will be responsible to oversee the laboratory operations across 3 different functional groups in Frederick,…
Est. 202,500 USD
Position Summary: The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing au…
Est. 202,500 USD
Position Summary: The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing au…
Est. 220,000 USD
The Senior Director Market Access Consulting will be responsible for the growth and development of consultative services supporting life sciences clients as a key leader of the consulting team within Precision AQ. Additi…
Est. 220,000 USD
The Senior Director Market Access Consulting will be responsible for the growth and development of consultative services supporting life sciences clients as a key leader of the consulting team within Precision AQ. Additi…
Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and m…
Est. 66,011 USD
At Precision AQ, our Associate Program Managers play a critical role in bringing client programs to life—ensuring projects run smoothly, deadlines are met, and teams stay aligned every step of the way. This is an excitin…
Est. 66,103 USD
At Precision AQ, our Associate Program Managers play a critical role in bringing client programs to life—ensuring projects run smoothly, deadlines are met, and teams stay aligned every step of the way. This is an excitin…
Est. 235,500 USD
The VP, Market Access Consulting will be responsible for the growth and development of consultative services supporting life sciences clients as a key leader of the consulting team within Precision AQ. Additionally, the…
Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and m…
Est. 120,000 EUR
Position Summary: The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing au…
Est. 120,000 EUR
Position Summary: The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing au…
Est. 120,000 PLN
Due to continued growth, Precision for Medicine is seeking an experienced Senior Manager/ Manager, Global Clinical Monitoring to join our Global Clinical Monitoring team. Based remotely in Poland, this role will have lin…
Est. 235,500 USD
The VP, Market Access Consulting will be responsible for the growth and development of consultative services supporting life sciences clients as a key leader of the consulting team within Precision AQ. Additionally, the…
Est. 120,000 PLN
Due to continued growth, Precision for Medicine is seeking an experienced Senior Manager/ Manager, Global Clinical Monitoring to join our Global Clinical Monitoring team. Based remotely in Poland, this role will have lin…
Position Summary: The QA Specialist provides independent Quality support for GLP and GCLP studies by performing document review, protocol and experiment record review, data review, and quality event oversight activities.…
Position Summary: The QA Specialist provides independent Quality support for GLP and GCLP studies by performing document review, protocol and experiment record review, data review, and quality event oversight activities.…
Est. 202,500 USD
Position Summary: Works cross functionally to develop partnership strategies for clinical trials and programs and works closely with our project teams to provide oversight, strategic expertise in the planning, coordinati…
Est. 202,500 USD
Position Summary: Works cross functionally to develop partnership strategies for clinical trials and programs and works closely with our project teams to provide oversight, strategic expertise in the planning, coordinati…