Top 16 Quality assurance biotech Jobs in San Francisco Bay Area Ca

Manager, Quality Assurance, Compliance
Vaxcyte —San Carlos, CA
- $151,000 - $176,000 a year
- Hybrid work
- 5 years
- Office
- Bachelor's degree
Senior Manager, Quality Assurance Program
Rigel Pharmaceuticals, Inc. —South San Francisco, CA
- $140,000 - $170,000 a year
- Full-time
- Hybrid work
- 6 years
- Travel
- Senior level
- Paid holidays
- Disability insurance
Quick Apply
QA Manager, Training Services
Penumbra —Alameda, CA
- $137,000 - $194,000 a year
- 5 years
- Office
- Bachelor's degree
- Paid parental leave
- AD&D insurance
Associate QA Operations Director - Systems and Process
Exelixis, Inc. —Alameda, CA
- $176,000 - $250,500 a year
- Email
- Computer Science
- Bachelor of Science
- Office
- Paid holidays
- Disability insurance
NGS Lab Technician (Night Shift)
Angstrom Innovation —Berkeley, CA
- From $28 an hour
- Part-time
- Research
- Continuous improvement
- Organizational skills
Quick Apply
4d
DeRisi Lab – Junior/Assistant/Associate Specialist
UC San Francisco Academic —San Francisco, CA
- $55,000 - $88,000 a year
- Online Application
- 3 years
- Master's degree
- University
Executive Director, CMC QA
Ultragenyx Pharmaceutical —South San Francisco, CA
- $294,100 - $363,300 a year
- Microsoft Word
- Microsoft Excel
- Office
- Gym membership
10d
Executive Director, CMC QA
Ultragenyx Pharmaceutical —Novato, CA
- $294,100 - $363,300 a year
- Microsoft Word
- Microsoft Excel
- Office
- Gym membership
10d
Senior Manager, Quality Control Data Analyst
Vaxcyte —San Carlos, CA
- $166,000 - $194,000 a year
- Hybrid work
- Office
- 3 years
- SQL
Senior Manager, Quality Control
Vir Biotechnology —San Francisco, CA
- $142,500 - $199,000 a year
- Full-time
- Bachelor of Science
- Office
- 8 years
- Commuter assistance
- Paid holidays
Quick Apply
Sr Manager, QA Operations
Kyverna Therapeutics —Emeryville, CA
- $160,000 - $180,000 a year
- Full-time
- Hybrid work
- Master's degree
- Bachelor's degree
- Travel
QC Lead/Manager
Neurona Therapeutics —South San Francisco, CA
- $110,000 - $125,000 a year
- 5 years
- Master's degree
- Bachelor's degree
Quick Apply
Senior Director, Validation and Quality Engineering
Allogene Therapeutics —South San Francisco, CA
- $230,000 - $270,000 a year
- Full-time
- Hybrid work
- Engineering
- Office
- Microsoft Office
- Health insurance
Quick Apply
Stability Manager
Vaxcyte —San Carlos, CA
- $147,000 - $171,000 a year
- Hybrid work
- Bachelor of Science
- Databases
- 8 years
Senior Manager, Microbiology Support for Global ASAT
Vaxcyte —San Carlos, CA
- $166,000 - $194,000 a year
- 7 years
- Bachelor of Science
- Continuous improvement
Staff Compliance Validation Engineer
CUTERA INC —Brisbane, CA
- $130,000 - $150,000 a year
- Full-time
- Engineering
- 8 years
- Analysis skills
Quick Apply

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Executive Director, CMC QA
Ultragenyx Pharmaceutical —South San Francisco, CA
Strong quality risk management capability and proficiency with root cause analysis, risk assessment, trend analysis, and decision-making tools.
$294,100 - $363,300 a year
10d
QA Specialist - Full Time & Temporary
Bionova Scientific LLC —Fremont, CA
2-4 years of combined manufacturing process development, manufacturing, analytical development, and/or quality control experience in biotechnology or…
$36 - $48 an hour
4d

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Andelyn Biosciences, Inc —Columbus, OH
Ensure manufacturing, testing and release, and distribution of gene therapy products are consistent and meet all relevant regulatory requirements including…
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Validation Engineer
PSC Biotech —Columbus, OH
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Manager, Quality Assurance, Compliance

Vaxcyte -
San Carlos, CA

Apply Now

Job Details

$151,000 - $176,000 a year

Qualifications

GMP
Quality risk management
Quality assurance experience within pharmaceutical industry
ICH Q10
Cross-functional communication

Full Job Description

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary:

Vaxcyte is seeking a Manager, Quality Assurance, Compliance who is responsible for providing day-to-day operational oversight governance and strategic oversight of key Quality System processes, with a primary focus on leading Change Control governance and deviation/investigation oversight review board leadership. This role insures consistent, risk-based decision making, inspection readiness, and cross-functional accountability across quality systems. The Manager acts as an operational backbone a governance leader for cross-functional quality processes, proactively identifying systemic risks, ensuring procedural compliance, driving performance through KPIs, and presenting quality system health and trends through Management Review.

Essential Functions:

Change Control Governance & Board Leadership
- Lead and coordinate the Change Control Review Board (CCRB), including agenda development, facilitation, quorum confirmation, and documentation of decisions.
- Perform pre-CCRB QA review of Change Requests to ensure completeness, clarity, and appropriate risk classification prior to board review.
- Verify alignment of Change Requests with applicable SOPs, including confirmation of CCRB-required versus discretionary changes.
- Provide QA authority on change classification, risk assessment, impact evaluation, and implementation strategy.
- Own CCRB performance metrics, including cycle time, risk categorization trends, backlog, and recurring impact areas. Present trends and risk signals to senior leadership and during Management Review.
Deviation and Investigation Governance
- Lead or co-lead Deviation Review Boards to ensure consistent, risk-based decision making.
- Ensure appropriate classification (minor, major, critical) and scientifically sound investigations.
- Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
- Ensure linkage between deviations, CAPA, and change controls to prevent recurrence and address systemic risk.
Quality Metrics and Management Review
- Own development, maintenance, and reporting of Quality System KPIs related to Change Control, Deviations, Investigations, and CAPA.
- Perform routine trend analysis and signal detection to identify emerging compliance risks.
- Prepare and present Quality System performance data during Management Review.
Inspection Readiness and Regulatory Support
- Serve as Subject Matter Expert (SME) for Change Control and Deviation processes during regulatory inspections and audits.
- Support preparation of audit responses and ensure timely and compliant closure of observations.
- Maintain processes in a continuous state of inspection readiness.

Requirements:

Bachelor’s degree in Life Sciences or a related field.
5+ years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industry. Other combinations of education and/or experience may be considered.
Experience leading cross-functional governance boards strongly preferred.
Strong understanding of ICH Q10, risk management principles, and inspection expectations.
Experience with electronic Quality Management Systems (eQMS) strongly preferred.
In-depth knowledge of cGMP regulations.
Excellent organizational skills, attention to detail, and ability to manage multiple priorities.
Strong interpersonal and communication skills to work effectively across functions and with external partners.

Reports to: Associate Director, QA, Compliance

Location: San Carlos, CA; Hybrid

Compensation:

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $151,000 – $176,000 (SF Bay Area). Salary ranges for non-California locations may vary.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Apply Now

Refine Your Search

quality assurance biotech jobs in san francisco bay area ca

Manager, Quality Assurance, Compliance

Senior Manager, Quality Assurance Program

QA Manager, Training Services

Associate QA Operations Director - Systems and Process

NGS Lab Technician (Night Shift)

DeRisi Lab – Junior/Assistant/Associate Specialist

Executive Director, CMC QA

Executive Director, CMC QA

Senior Manager, Quality Control Data Analyst

Senior Manager, Quality Control

Sr Manager, QA Operations

QC Lead/Manager

Senior Director, Validation and Quality Engineering

Stability Manager

Senior Manager, Microbiology Support for Global ASAT

Staff Compliance Validation Engineer

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Join our Mission to Protect Humankind!

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Requirements:

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