Top 223 Sr. manager / associate director, quality audits Jobs in Oakland Ca

Sr. Manager / Associate Director, Quality Audits
Personalis, Inc —Fremont, CA
- $165,000 - $210,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- 8 years
- Analysis skills
- Commuter assistance
- Employee stock purchase plan
5d
Quality Control Inspector (CMM)
CHawk Technology —Hayward, CA
- $22 - $30 an hour
- Overtime
- Ability to walk for extended periods
- Mid-level
- High school diploma or GED
- Health savings account
- Health insurance
Quick Apply
Consultant - Product Quality & Safety - Life Sciences & Healthcare
Deloitte —San Francisco, CA
- $88,700 - $170,900 a year
- Full-time
- Up to 50% travel
- Bachelor's degree
- Product management
Director of Critical Environmental Programs (GxP): Fremont, CA
ADVANCED BUILDING MAINTENANCE INC —Fremont, CA
- $150,000 - $180,000 a year
- Full-time
- Up to 50% travel
- Ability to walk for extended periods
- Bachelor's degree
- Health insurance
- Paid time off
Quick Apply
Quality Control / Day & Night Supervisor
First Choice Building Maintenance —Pleasanton, CA
- $20 - $25 an hour
- Weekends as needed
- Background check
- Spanish
- Ability to walk for extended periods
- 401(k)
Quick Apply
Supervisor, Quality Inspection
Benchmark Electronics, Inc —Concord, CA
- $86,014 - $107,517 a year
- Overtime
- Mid-level
- Bachelor's degree
- Organizational skills
- Dental insurance
- 401(k)
Principal Quality Operations Specialist
PG&E Corporation —Oakland, CA
- $125,000 - $226,000 a year
- Hybrid work
- PMP
- Bachelor of Science
- Office
4d
Supplier Quality Engineer/Wiring Harnesses
Formel D USA —Newark, CA
- $41 - $44 an hour
- Full-time
- Microsoft Excel
- Engineering
- Mid-level
Quick Apply
Manager, Quality & Safety
Fictiv —Oakland, CA
- $125,000 - $140,000 a year
- Remote
- Bachelor of Science
- Engineering
- Travel
- Health insurance
- Dental insurance
Quick Apply
13d
Director of Quality Excellence
PHIL —San Francisco, CA
- $160,000 - $190,000 a year
- Full-time
- Remote
- System design
- Analysis skills
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
10d
Director, Quality
Astra —Alameda, CA
- $211,564 - $250,000 a year
- Full-time
- Engineering
- Mentoring
- Fair chance
Quick Apply
Sr. Quality Specialist – Post Market & Supplier Quality
Abbott Laboratories —Alameda, CA
- $90,000 - $180,000 a year
- Full-time
- 5 years
- Bachelor's degree
- Travel
- Health insurance
- Tuition reimbursement
Director, GMP Quality Assurance
Jade Biosciences —San Francisco, CA
- $210,000 - $235,000 a year
- Remote
- Microsoft Word
- Research
- Master's degree
Quick Apply
Quality Manager
SirenOpt —San Leandro, CA
- $160,000 - $190,000 a year
- Bachelor of Science
- Supervising experience
- Team management
- Paid holidays
- Health insurance
Sr. Manager/Associate Director, Market Access
Personalis, Inc —Fremont, CA
- $160,000 - $220,000 a year
- Overtime
- Remote
- 8 years
- Analysis skills
- Bachelor's degree
- Commuter assistance
- Employee stock purchase plan
Supplier Quality Engineer, Lead
FluidStack —San Francisco, CA
- $150,000 - $250,000 a year
- Email
- Remote
- Mentoring
- Fair chance
- Senior level
- Dental insurance
- Paid time off
Director of Quality
Attalon, Inc. —Richmond, CA
- $152,145 - $262,423 a year
- Full-time
- Engineering
- Senior level
- Business
Quick Apply
7d
Quality Assurance Manager
Reyes Coca-Cola Bottling —San Leandro, CA
- $119,560 - $149,450 a year
- Full-time
- 3 years
- Master's degree
- High school diploma or GED
- Health insurance
- Dental insurance
Quick Apply
Quality Management Director
Episcopal Community Services (ECS) —San Francisco, CA
- $157,000 - $161,576 a year
- Full-time
- Current TB test
- 3 years
- Supervising experience
Quick Apply
Director, Quality Performance / Job Req 956626885
ALAMEDA ALLIANCE FOR HEALTH —Alameda, CA
- $167,440 - $251,160 a year
- Full-time
- Nursing
- Microsoft Excel
- RN License

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Sr. Manager / Associate Director, Quality Audits

Personalis, Inc -
Fremont, CA

Apply Now

Job Details

Full-time
$165,000 - $210,000 a year
5 days ago

Benefits

Commuter assistance
Employee stock purchase plan
Health insurance
On-site gym
Dental insurance
Tuition reimbursement
Vision insurance
401(k) matching

Qualifications

Clinical laboratory experience
ICH guidelines
Biomedical regulatory compliance
Technical Proficiency
FDA regulations
Senior leadership
Quality assurance experience within healthcare

Full Job Description

Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to Veterans Affairs' Million Veteran Program. To enable cancer and population sequencing, Personalis' Clinical Laboratory was built with a focus on clinical accuracy, quality, big data, scale and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists-accredited. 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

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Refine Your Search

sr. manager / associate director, quality audits jobs in oakland ca

Sr. Manager / Associate Director, Quality Audits

Quality Control Inspector (CMM)

Consultant - Product Quality & Safety - Life Sciences & Healthcare

Director of Critical Environmental Programs (GxP): Fremont, CA

Quality Control / Day & Night Supervisor

Supervisor, Quality Inspection

Principal Quality Operations Specialist

Supplier Quality Engineer/Wiring Harnesses

Manager, Quality & Safety

Director of Quality Excellence

Director, Quality

Sr. Quality Specialist – Post Market & Supplier Quality

Director, GMP Quality Assurance

Quality Manager

Sr. Manager/Associate Director, Market Access

Supplier Quality Engineer, Lead

Director of Quality

Quality Assurance Manager

Quality Management Director

Director, Quality Performance / Job Req 956626885

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