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Director Quality Operations Jobs (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 ...

FM Industries

Director, Quality Operations

Fremont, CA · On-site

$162K - $211K/yr

The Director of Quality Operations is responsible for the planning, leadership and operational execution of the organization's quality departments at the site level as well as customer and supplier ...

FM Industries

Director, Quality Operations

Livermore, CA · On-site

$162K - $211K/yr

The Director of Quality Operations is responsible for the planning, leadership and operational execution of the organization's quality departments at the site level as well as customer and supplier ...

Quorum Health

Director Quality Operations

Brentwood, TN · On-site

Director Quality Operations Remote Position with 50% Travel Requirement Registered Nurse (RN) License Required Must reside in one of the States listed below to be eligible for this position: Arkansas ...

Curia, Inc.

Director, Quality Operations Support

Albany, NY · On-site +1

$148K - $184K/yr

Director, Quality Operations Support - Remote (Greater Boston or NYS) Build your future at Curia, where our work has the power to save lives. The Director of Quality Operations Support is responsible ...

AMRI

Director, Quality Operations Support

Albany, NY

$148K - $184K/yr

Director, Quality Operations Support - Remote (Greater Boston or NYS) Build your future at Curia, where our work has the power to save lives. The Director of Quality Operations Support is responsible ...

Danaher

Senior Director Quality Operations

Chaska, MN · On-site

The Senior Director, Quality Operations - Clinical Chemistry Immunoassay (CCIA) North America provides senior-level operational quality leadership for the Chaska, Minnesota and San Diego, California ...

Cosette Pharmaceuticals Inc.

The Senior Director, Quality Operations will suppor t quality initiatives and ensure compliance with cGMP's are maintained at the manufacturing facility. Essential Functions and Responsibilities

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Director Quality Operations information

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$34K

$107.7K

$179.5K

How much do director quality operations jobs pay per year?

As of Aug 1, 2026, the average yearly pay for director quality operations in the United States is $107,680.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,500.00 and $135,500.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Director of Quality Operations, and why are they important?

To thrive as a Director of Quality Operations, you need expertise in quality management systems, regulatory compliance, and process improvement, often supported by a relevant degree and extensive experience in quality assurance. Familiarity with tools such as Six Sigma, ISO standards, and quality management software is typically required, along with certifications like ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE). Strong leadership, strategic thinking, and effective communication are vital soft skills for driving cross-functional initiatives and fostering a culture of continuous improvement. These skills ensure that organizational processes meet regulatory standards, reduce risk, and support business objectives.

What jobs pay 500,000 a year in the US?

In the US, high-level executive roles such as Chief Executive Officers (CEOs), Chief Operating Officers (COOs), and Chief Financial Officers (CFOs) often have annual compensation exceeding $500,000, especially in large corporations. Additionally, specialized roles like certain surgeons, investment bankers, and successful entrepreneurs can also reach or surpass this income level, often requiring extensive experience, advanced skills, and significant responsibility.

What are the main challenges a Director of Quality Operations typically faces when coordinating cross-functional teams?

Directors of Quality Operations often encounter the challenge of aligning diverse teams—such as manufacturing, regulatory, and R&D—toward shared quality goals. Balancing differing priorities, managing communication across departments, and ensuring consistent adherence to quality standards can be complex. Effective leaders in this role foster collaboration, establish clear processes, and proactively address potential bottlenecks to drive continuous improvement and compliance. Developing strong interpersonal relationships and maintaining transparency are crucial to successfully navigating these challenges.

What does a Director of Quality Operations do?

A Director of Quality Operations oversees the quality assurance and control processes within an organization, ensuring that products or services meet established standards. They develop and implement quality management systems, lead compliance initiatives, and coordinate cross-functional teams to improve operational efficiency. This role often involves monitoring regulatory requirements, managing audits, and driving continuous improvement projects. The Director of Quality Operations plays a key leadership role in maintaining customer satisfaction and supporting business objectives.

What does a director of QA do?

A director of Quality Assurance (QA) oversees the development and implementation of quality standards and processes to ensure products or services meet company and industry requirements. They lead QA teams, coordinate testing efforts, analyze quality metrics, and collaborate with other departments to improve overall quality and compliance. Strong leadership, knowledge of quality management systems, and relevant certifications are often required in this role.

How much does a QA director make in the US?

A Quality Assurance (QA) Director in the US typically earns between $100,000 and $160,000 annually, depending on experience, industry, and location. Senior roles with extensive experience and certifications can earn higher salaries, often exceeding $180,000. Compensation may also include bonuses and benefits related to leadership and quality management responsibilities.

Is operations director a high position?

An Operations Director is a high-level leadership role responsible for overseeing company operations, strategic planning, and process improvements. It typically requires extensive experience, strong management skills, and often a background in business or operations management, making it a senior position within an organization.
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Director Quality Operations jobs near you
Infographic showing various Director Quality Operations job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 84% Full Time, 12% Part Time, 1% Temporary, and 2% Contract. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution, with an average salary of $107,680 per year, or $51.8 per hour.

Director, Quality Operations

Immunome, Inc.

Bothell, WA • On-site

Full-time

Posted 9 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 submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. 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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