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How much do quality assurance biotech jobs pay per hour?

As of Aug 13, 2026, the average hourly pay for quality assurance biotech in Bothell, WA is $32.74, 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 are popular job titles related to Quality Assurance Biotech jobs in Bothell, WA? For Quality Assurance Biotech jobs in Bothell, WA, the most frequently searched job titles are:
What job categories do people searching Quality Assurance Biotech jobs in Bothell, WA look for? The top searched job categories for Quality Assurance Biotech jobs in Bothell, WA are:
What cities near Bothell, WA are hiring for Quality Assurance Biotech jobs? Cities near Bothell, WA with the most Quality Assurance Biotech job openings:
Quality Assurance Biotech jobs near you
Infographic showing various Quality Assurance Biotech job openings in Bothell, WA as of August 2026, with employment types broken down into 1% As Needed, 75% Full Time, 19% Part Time, 4% Contract, and 1% Nights. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $69,256 per year, or $33.3 per hour.

Director, Quality Operations

Immunome, Inc.

Bothell, WA • On-site

Full-time

Posted 21 days ago

Job description

Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
Position Overview
The Director, Quality Operations will report to the Senior Director, Quality Assurance and provide strategic operational leadership and oversight across assigned programs related to clinical and commercial. This role will lead day-to-day activities around commercialization of Varegacestat and continuing Varegacestat clinical programs. Additional projects will eventually be added. They will work cross-functionally and with internal and external partners to ensure product quality throughout the development lifecycle and provide strategic quality leadership aligned with company objectives. Experience with small molecules and biologics is required.
Responsibilities
Quality Operations
  • Oversee quality aspects of starting material, intermediates, drug substance and drug product manufacturing as well as packaging/labeling activities.
  • Review and approve specifications affecting product quality and oversee the development of master batch records, process and method validation/protocol reports and other technical documents created to support all stages of the product lifecycle, from development to commercialization.
  • Disposition clinical and commercial batches.
  • Ensure effective CAPA management, change controls, deviations, and other GMP-related processes are followed during manufacturing and testing of products.
  • Interact with manufacturing, clinical, or other functional areas that impact quality operations and provide support as needed.
  • Perform risk assessments and implement appropriate quality and process controls to ensure proper oversight of production activities.
  • Support vendor qualification program and monitor vendor performance.
  • Prompt communication to management of potential compliance issues.
  • Participate in internal and external project team meetings.

Documentation and Record Control
  • Perform periodic reviews and revisions of SOPs, policies, and Quality Agreements to align with regulatory updates and business needs.
  • Establish, review and/or approve Quality Agreements and ensure they are properly stored and managed.
  • Manage other internal and external documentation related to QA operations.

Regulatory Compliance and Inspection Readiness
  • Ensure external parties are inspection-ready, in compliance with regulatory requirements, and prepared for GMP audits or inspections from FDA or other international regulatory bodies.
  • Collaborate with regulatory affairs and cross-functional teams to support regulatory submissions, including providing necessary documentation and ensuring compliance with filing requirements.
  • Support site preparation for regulatory inspections including personnel preparation and training.
  • Participate in Quality Management Review meetings, as needed.
  • Assist in updating CMC sections of regulatory and quality documents.

Operational Leadership and Continuous Improvement
  • Drive continuous improvement initiatives across quality operations to enhance operational efficiency, reduce risk, and improve product quality.
  • Provide strategic direction and hands-on leadership for operations teams, ensuring alignment with business goals and regulatory demands.
  • Develop and implement metrics to monitor and report on the performance of Operations, identifying areas for improvement and ensuring corrective actions are implemented.
  • Promote a strong Quality culture within the organization. Identify compliance risks and be a part of the solution through ownership and collaboration.

Qualifications
  • A minimum of 10 years of experience in Quality Assurance and GMP compliance within a pharmaceutical or biotechnology environment, or equivalent.
  • Extensive experience supporting outsourced manufacturing models, including oversight of CMOs and external service providers.
  • Experience working with small molecules and biologics (ideally ADCs).
  • Demonstrated senior-level experience leading global regulatory inspections and managing inspection outcomes.
  • Significant experience supporting development-stage programs through commercial operations.
  • Proven experience with internal and external audits, CAPA management, and continuous improvement initiatives.
  • Ability to travel up to 20% to support audits and regulatory inspections, domestic and international.

Knowledge and Skills
  • Deep technical knowledge of global GMP and GDP regulations, regulatory inspection expectations, and quality system requirements across development-stage and commercial operations.
  • Demonstrated expertise in inspection readiness, regulatory inspections, and inspection response management, including FDA Form 483 responses, commitments, and remediation strategies.
  • Strong understanding of quality systems, audit programs, CAPA management, recalls and risk-based compliance approaches in outsourced manufacturing environments.
  • Proven ability to lead quality governance, management/quality review processes, and regulatory surveillance activities.
  • Ability to assess, prioritize, and mitigate quality and compliance risks across CMOs, vendors, and internal operations.
  • Strong leadership presence with the ability to effectively influence executive leadership and cross-functional stakeholders.
  • Excellent verbal, written, interpersonal, and communication skills, with the ability to clearly convey complex quality and compliance topics.

Washington State Pay Range
$212,149-$239,998 USD
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).

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