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Director Quality Jobs in Bothell, WA (NOW HIRING)

Immunome, Inc.

Director, Quality Operations

Bothell, WA · On-site

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 ...

Omeros

Director, Quality Control

Seattle, WA

The Director, Quality Control will provide strategic leadership in managing a growing team of scientists responsible for QC-related activities and operations. This individual will be responsible for ...

Omeros Corp.

Director, Quality Control

Seattle, WA · On-site

The Director, Quality Control will provide strategic leadership in managing a growing team of scientists responsible for QC-related activities and operations. This individual will be responsible for ...

Blue Origin

Director, Design Quality

Seattle, WA · On-site

Director of Design Quality is a hands-on hardware quality leader who believes that quality must be designed in, not inspected out. You will build and lead the Design Quality function from the ground ...

Blue Origin, LLC

Director, Design Quality

Seattle, WA · On-site

Director of Design Quality is a hands-on hardware quality leader who believes that quality must be designed in, not inspected out. You will build and lead the Design Quality function from the ground ...

VRC Engineered Solutions

Quality Manager

Woodinville, WA · On-site

$89K - $112K/yr

Approximately 25% between locations Direct Reports: Quality Engineers (CDA & WDN) Salary Range: $89,500.00 to $112,000 USD Position Summary Responsible for leading, planning, organizing, directing ...

VRC Engineered Solutions

Quality Manager

Woodinville, WA · On-site

$89K - $112K/yr

Approximately 25% between locations Direct Reports: Quality Engineers (CDA & WDN) Salary Range: $89,500.00 to $112,000 USD Position Summary Responsible for leading, planning, organizing, directing ...

Pwc

Payer Quality Consultant, Director

Seattle, WA · On-site

$155K - $410K/yr

Industry/Sector Health Services Specialism Operations Management Level Director & Summary The Opportunity As a Payer Quality Consultant, Director, you will lead strategic initiatives within our ...

Pwc

Payer Quality Consultant, Director

Seattle, WA · On-site

$155K - $410K/yr

Industry/Sector Health Services Specialism Operations Management Level Director & Summary At PwC ... You are expected to be a guardian of PwC's reputation, understanding that quality, integrity ...

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Director Quality information

See Bothell, WA salary details

$35.1K

$142.3K

$241.9K

How much do director quality jobs pay per year?

As of Aug 10, 2026, the average yearly pay for director quality in Bothell, WA is $142,286.00, according to ZipRecruiter salary data. Most workers in this role earn between $103,100.00 and $171,100.00 per year, depending on experience, location, and employer.

What does a director of quality do?

A Director of Quality oversees the quality assurance and quality control processes within an organization to ensure that products or services meet established standards and regulatory requirements. They develop and implement quality management systems, lead teams responsible for inspections and audits, and work closely with other departments to promote continuous improvement. The Director of Quality also analyzes quality data, manages compliance with industry regulations, and often interacts with customers or external auditors to address quality concerns.

What are the key skills and qualifications needed to thrive as a director of quality, and why are they important?

To succeed as a Director of Quality, you need extensive knowledge in quality management systems, regulatory compliance, and process improvement, often supported by a bachelor's or master's degree in a relevant field. Familiarity with tools such as Six Sigma, ISO standards, and quality auditing software, along with certifications like CQE or Six Sigma Black Belt, is typical. Exceptional leadership, analytical thinking, and effective communication are critical soft skills for driving quality initiatives and leading cross-functional teams. These competencies ensure organizational standards are upheld, continuous improvement is achieved, and regulatory risks are minimized.

What is the difference between Director Quality vs Quality Manager?

AspectDirector QualityQuality Manager
CredentialsBachelor's or Master’s in Quality Management, Engineering, or related field; certifications like ASQ CQE or CQABachelor's in Quality, Engineering, or related; certifications like ASQ CQE or CQA often preferred
Work EnvironmentStrategic leadership in quality initiatives, overseeing multiple departments or sitesOperational focus, managing daily quality processes and teams
Employer & Industry UsageUsed in manufacturing, healthcare, aerospace, and industries with complex quality systemsCommon in manufacturing, production, and service industries

The main difference between a Director Quality and a Quality Manager lies in their scope and strategic focus. The Director Quality typically oversees the entire quality program at a higher level, setting policies and long-term goals, while the Quality Manager handles daily operations and implements quality procedures. Both roles require similar credentials and certifications, but their responsibilities and strategic influence differ significantly.

How does a director of quality typically collaborate with cross-functional teams to drive continuous improvement initiatives?

A Director of Quality plays a key role in partnering with departments such as manufacturing, engineering, supply chain, and regulatory affairs to identify and resolve process inefficiencies and ensure compliance with quality standards. They often lead cross-functional meetings, facilitate root cause analyses, and champion a culture of continuous improvement by implementing best practices and quality tools like Six Sigma or Lean methodologies. Effective communication and the ability to influence stakeholders at all levels are essential, as the Director of Quality ensures that all departments are aligned with organizational quality goals and regulatory requirements.
What are the most commonly searched types of Quality jobs in Bothell, WA? The most popular types of Quality jobs in Bothell, WA are:
What job categories do people searching Director Quality jobs in Bothell, WA look for? The top searched job categories for Director Quality jobs in Bothell, WA are:
What cities near Bothell, WA are hiring for Director Quality jobs? Cities near Bothell, WA with the most Director Quality job openings:
Director Quality jobs near you
Infographic showing various Director Quality 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 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $142,286 per year, or $68.4 per hour.

Director, Quality Operations

Immunome, Inc.

Bothell, WA • On-site

Full-time

Posted 19 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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