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Quality Assurance Biotech Jobs in San Ramon, CA (NOW HIRING)

Aspect Biosystems

Head of Quality Assurance

Fremont, CA · On-site

$191 - $202/hr

Biotech Industry Tenure: 10+ years of progressive Quality Assurance leadership experience within a GMP-regulated biotech, pharmaceutical, or advanced biologics environment. * Modality Expertise:

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How much do quality assurance biotech jobs pay per hour?

As of Aug 27, 2026, the average hourly pay for quality assurance biotech in San Ramon, CA is $32.73, according to ZipRecruiter salary data. Most workers in this role earn between $20.96 and $38.41 per hour, depending on experience, location, and employer.

What is a quality assurance biotech?

A Quality Assurance (QA) Biotech job involves ensuring that biotechnology products meet regulatory and company standards for safety, efficacy, and quality. QA professionals develop and implement quality systems, conduct audits, review documentation, and ensure compliance with Good Manufacturing Practices (GMP) and other regulations. They collaborate with various departments, including manufacturing, R&D, and regulatory affairs, to maintain product integrity. Their role is critical in preventing defects, ensuring consistent processes, and maintaining compliance with industry standards.

What are the key skills and qualifications needed to thrive in quality assurance biotech?

To thrive as a Quality Assurance Biotech, you need a solid understanding of biotechnology processes, quality control methodologies, and regulatory standards such as GMP, often supported by a degree in biology, chemistry, or a related field. Familiarity with laboratory information management systems (LIMS), documentation software, and industry certifications like ASQ or GMP training is highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills are valued soft skills in this role. These abilities ensure precise compliance with regulatory requirements, facilitate collaboration with cross-functional teams, and help maintain the integrity and safety of biotech products.

What are the most common challenges faced by quality assurance professionals in the biotech industry?

Quality Assurance professionals in biotechnology often encounter challenges related to staying up-to-date with evolving regulatory requirements and ensuring that all processes consistently meet strict quality standards. Additionally, managing thorough documentation and collaborating across various departments—such as research, manufacturing, and regulatory affairs—can be complex. Those in the role may also need to respond quickly to deviations or quality events, requiring both proactive problem-solving and excellent organizational skills. However, overcoming these challenges is highly rewarding, as it directly contributes to maintaining the safety and efficacy of biotech products.

What job categories do people searching Quality Assurance Biotech jobs in San Ramon, CA look for?

The top searched job categories for Quality Assurance Biotech jobs in San Ramon, CA are:

What cities near San Ramon, CA are hiring for Quality Assurance Biotech jobs?

Cities near San Ramon, CA with the most Quality Assurance Biotech job openings:

Quality Assurance Biotech jobs near you
Infographic showing various Quality Assurance Biotech job openings in San Ramon, CA as of August 2026, with employment types broken down into 1% As Needed, 82% Full Time, 12% Part Time, 4% Contract, and 1% Nights. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution, with an average salary of $68,084 per year, or $32.7 per hour.

Head of Quality Assurance

Fremont, CA

Aspect Biosystems
See more jobs at Aspect Biosystemsexternal

$191K - $202K/yr

Full-time

Re-posted 29 days ago

Job description

We are seeking a Head of Quality Assurance to join Aspect's technical operations team. Reporting to the Chief Technical Operations Officer, you will be directly responsible for establishing, scaling, and leading the Quality Assurance (QA) team and directing overall GxP compliance for our bioprinted tissue therapeutics. You will be accountable for embedding a culture of quality, integrity, and compliance across the entire product value chain, from early development through clinical manufacturing.

Responsibilities 

  • Establish and maintain a phase-appropriate, GMP compliant Quality Management System (QMS) across all development and manufacturing activities.
  • Own and oversee core QA functions, including Document Control, Training, Change Control, Deviations, CAPA, and OOS investigations.
  • Serve as the Management Representative and lead all inspection readiness activities and host internal, vendor, and regulatory agency inspections (FDA, EMA, Health Canada).
  • Lead Quality oversight for the GMP Cell Manufacturing facility, ensuring adherence to regulatory filings and operational SOPs.
  • Primary Quality contact for regulatory agency engagement and external partner collaborations.
  • Provide support to the QC functions responsible for developing, validating, and executing method documentation for product characterization, release testing, and stability programs.
  • Ensure data integrity, traceability, and reliability for all GxP analytical and nonclinical data used in regulatory decisions.
  • Build and lead a high-performing QA team, managing performance, professional development, and resource planning.
  • Collaborate cross-functionally and contribute quality expertise to all regulatory submissions (IND, CTA) through authoring, review, and approval of relevant documentation.

Qualifications & Experience

  • Education: Bachelor's, Master's, or Ph.D. in Life Sciences, Biotechnology, Chemistry, Engineering, or a related scientific discipline. Advanced certifications (e.g., ASQ CQA/CQM) are an asset.
  • Biotech Industry Tenure: 10+ years of progressive Quality Assurance leadership experience within a GMP-regulated biotech, pharmaceutical, or advanced biologics environment.
  • Modality Expertise: Strong preference for experience in Cell/Gene Therapy, Biologics, Tissue Engineering, or Advanced Therapy Medicinal Products (ATMPs).
  • Regulatory Compliance & Inspections: Expert understanding and practical application of global regulatory guidelines (FDA, EMA, Health Canada, ICH). Proven track record of successfully hosting regulatory agency inspections and acting as the primary quality liaison.
  • Phase-Appropriate QMS Design: Demonstrated success in establishing, scaling, and maintaining a phase-appropriate Quality Management System (QMS) from early-stage development through clinical trials and commercial readiness.
  • Submissions Experience: Direct experience authoring, reviewing, and approving Quality/CMC sections for regulatory submissions (e.g., IND, CTA, or equivalent).
  • Team Builder & Mentor: Proven ability to build a high-performing QA organization from the ground up, with a focus on resource planning, talent development, and embedding a collaborative culture of quality.

The hiring range for this role is $191,000 - $202,000, annually. Our ranges are based on market data. Offered salaries will be based on a combination of factors including, but not limited to, job-related knowledge, skills, education, and experience. For candidates who exceed role requirements, we are open to exploring above-range offers. Note that base salary is just one part of the overall compensation at Aspect. Members of the Aspect team also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.

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