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Director Quality Jobs (NOW HIRING)

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 ...

Walmart

Director, Quality Assurance

Springdale, AR · On-site

$110K - $220K/yr

The (USA) Director, Quality Assurance leads the development and execution of comprehensive quality assurance programs to ensure consistent product excellence. This role oversees quality processes ...

Away

Director, Quality Assurance

New York, NY · On-site

$150K - $165K/yr

Join The Crew We are hiring a Director of Quality Assurance to lead our Quality team. This role reports to the Head of Operations and takes Away further by owning the strategic roadmap to optimize ...

Walmart

Director, Quality Assurance

Tontitown, AR · On-site

$110K - $220K/yr

The (USA) Director, Quality Assurance leads the development and execution of comprehensive quality assurance programs to ensure consistent product excellence. This role oversees quality processes ...

Textron

Director, Quality Assurance

Wilmington, MA

Job Summary The Quality Assurance Director is an advanced technical resource in the principles and application of quality systems and compliance, responsible for developing goals, objectives and the ...

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 ...

Walmart

Director, Quality Assurance

Cave Springs, AR · On-site

$110K - $220K/yr

The (USA) Director, Quality Assurance leads the development and execution of comprehensive quality assurance programs to ensure consistent product excellence. This role oversees quality processes ...

Hearst

Director, Quality Assurance

Tampa, FL · Hybrid

The Director, Quality Assurance is a hybrid-based opportunity in Tampa that will lead and scale a modern quality engineering and automation organization. This role is responsible for defining and ...

Walmart

Director, Quality Assurance

Gravette, AR · On-site

$110K - $220K/yr

The (USA) Director, Quality Assurance leads the development and execution of comprehensive quality assurance programs to ensure consistent product excellence. This role oversees quality processes ...

Walmart

Director, Quality Assurance

Centerton, AR · On-site

$110K - $220K/yr

The (USA) Director, Quality Assurance leads the development and execution of comprehensive quality assurance programs to ensure consistent product excellence. This role oversees quality processes ...

Walmart

Director, Quality Assurance

Bella Vista, AR · On-site

$110K - $220K/yr

The (USA) Director, Quality Assurance leads the development and execution of comprehensive quality assurance programs to ensure consistent product excellence. This role oversees quality processes ...

Northern Light Health

Dir- Quality Mercy

Portland, ME · On-site

The Director, Quality is responsible for leading the development, execution, and oversight of the quality strategy at Hospital. The position has oversight of patient experience, patient safety, risk ...

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Director Quality information

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$31K

$125.6K

$213.5K

How much do director quality jobs pay per year?

As of Jul 20, 2026, the average yearly pay for director quality in the United States is $125,600.00, according to ZipRecruiter salary data. Most workers in this role earn between $91,000.00 and $151,000.00 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.
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Director Quality jobs near you

Director, Quality Control

Oruka Therapeutics

Menlo Park, CA • On-site, Remote

Full-time

Posted 24 days ago

Job description

About Us:
Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com
As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Job Title: Director, Quality Control
Location: Hybrid - Waltham, MA or Menlo Park, CA. Candidates will be required to be in-office 3 days/week Open to remote for non-local candidates.
Role Overview:
The Director, Quality Control - Combination Products will provide strategic and operational leadership for the Quality Control function supporting late-stage clinical development, analytical testing oversight for clinical drug substance and drug product, process performance qualification (PPQ), regulatory submissions, and commercial launch readiness for monoclonal antibody drug products and combination products, including pre-filled syringes and autoinjectors. This role will ensure timely, compliant, and scientifically sound oversight of release, stability, characterization, in-process, and method lifecycle activities performed at CMOs and contract testing laboratories.
This role is responsible for ensuring that all QC systems, analytical methods, and testing programs are inspection-ready and aligned with global regulatory expectations for commercial biologics. The Director will partner cross-functionally and externally to enable successful PPQ execution, analytical method validation, regulatory approval, and commercial launch readiness.
Key Responsibilities:
QC Strategy, Clinical Execution & Commercial Readiness
  • Develop and execute the enterprise QC strategy to support clinical product testing, Phase 3 clinical trials, PPQ, BLA submission, and commercial launch.
  • Build scalable QC systems, processes, governance, and organizational capabilities aligned with commercial-stage operations.
  • Establish and maintain analytical control strategies for drug substance (DS), drug product (DP), and combination products.
  • Ensure inspection readiness across QC operations, documentation, data integrity, and external partner networks.
  • Serve as a strategic advisor to Quality and CMC on analytical and QC-related risks, compliance considerations, and commercialization readiness.

Analytical Methods, Validation & Lifecycle Management
  • Lead and provide oversight of analytical method qualification, validation, transfer, verification, and lifecycle management in alignment with ICH, FDA, EMA, and global regulatory expectations.
  • Ensure all release, characterization, and stability-indicating methods are validated and commercially sustainable prior to BLA submission.
  • Oversee analytical comparability strategies, method bridging activities, and technology transfers across CMOs and contract laboratories.
  • Drive continuous improvement of analytical control strategies and testing programs through data trending and lifecycle management principles.
  • Ensure effective governance of reference standards, critical reagents, and assay performance monitoring programs.

PPQ, Validation & Continued Process Verification
  • Partner cross-functionally with Manufacturing, MSAT, and CMC teams to ensure QC readiness for PPQ execution and commercial manufacturing.
  • Provide QC oversight for in-process, release, and stability testing supporting validation campaigns and commercial supply.
  • Support continued process verification (CPV) programs through statistical trending, data analysis, and ongoing monitoring of product quality attributes.
  • Ensure timely and compliant batch disposition support through robust data review and issue escalation processes.

Combination Product Quality Control Leadership
  • Lead QC strategy and oversight for combination products, including pre-filled syringes, autoinjectors, and device constituent components.
  • Ensure compliant testing strategies for container closure integrity, product-device compatibility, particulate matter, functionality, and device-related attributes.
  • Oversee QC support for extractables and leachables (E&L), shipping validation, and stability programs associated with delivery systems.
  • Ensure QC operations and external partners comply with applicable combination product regulations, including 21 CFR Part 4 and relevant global guidance.
  • Support commercial readiness and lifecycle management for combination product manufacturing and release.

Clinical Product Analytical Testing Oversight and External Laboratory Management
  • Provide QC oversight for analytical testing of clinical drug substance and drug product, including release, stability, in-process, characterization, and comparability testing.
  • Provide oversight of contract testing laboratories and CMOs, including selection, qualification, governance, performance management, and risk mitigation.
  • Establish and maintain Quality Agreements and analytical governance structures aligned with commercial and regulatory expectations.
  • Lead oversight activities during critical manufacturing campaigns, investigations, audits, and inspection preparation activities.
  • Drive accountability and performance across the external analytical network to ensure reliable execution and compliance.
  • Investigations, Compliance & Quality Systems
  • Lead complex investigations involving OOS, OOT, deviations, laboratory events, complaints, and analytical discrepancies.
  • Ensure robust root cause analysis, effective CAPA implementation, and sustainable compliance solutions.
  • Champion data integrity principles (ALCOA+) and ensure compliance across QC systems, laboratories, and third-party partners.
  • Establish meaningful QC metrics, dashboards, and management review processes to drive operational excellence and continuous improvement.

Regulatory & Inspection Support
  • Author, review, and approve QC-related sections of regulatory submissions, including analytical methods, specifications, validation reports, comparability assessments, and stability data.
  • Serve as the QC Subject Matter Expert during regulatory inspections, pre-approval inspections (PAIs), and partner audits.
  • Lead responses to health authority questions, observations, and deficiency letters related to analytical and QC activities.
  • Maintain current knowledge of evolving global regulatory expectations for biologics and combination products.

Qualifications:
Required
  • Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related scientific discipline; advanced degree preferred.
  • 10+ years of progressive Quality Control and analytical experience within GMP biopharmaceutical environments, including late-stage clinical and commercial readiness activities.
  • Experience overseeing GMP analytical testing for clinical-stage biologic DS and DP, including release, stability, in-process, and/or comparability testing performed by CMOs or contract testing laboratories.
  • Demonstrated experience supporting BLA and/or MAA submissions, regulatory inspections, and commercial launch preparation.
  • Deep expertise in biologics analytical methods, including chromatographic, electrophoretic, cell-based, compendial, and microbiological techniques.
  • Extensive experience with analytical method validation, lifecycle management, comparability, and technology transfer.
  • Strong knowledge of cGMP regulations and global regulatory expectations, including 21 CFR Parts 210, 211, and 4.
  • Hands-on experience supporting combination products such as pre-filled syringes, autoinjectors, or related delivery systems.
  • Proven success leading QC support for PPQ campaigns, validation activities, and commercial manufacturing readiness.
  • Demonstrated experience managing CMOs, contract laboratories, and global external testing networks.
  • Strong understanding of data integrity principles, electronic systems, and QC compliance requirements.
  • Proven ability to build and scale Quality organizations in a fast-paced biotech environment.
  • Excellent leadership, communication, and cross-functional collaboration skills with the ability to influence at all organizational levels.

Preferred
  • Direct experience supporting successful BLA approval and commercial product launch.
  • Experience in a rapidly growing biotechnology company transitioning to commercial operations.
  • Knowledge of extractables/leachables, container closure systems, and device constituent testing.
  • Experience implementing or optimizing LIMS, stability systems, and digital QC infrastructure.
  • Experience supporting global regulatory filings and international commercialization activities.

Compensation:
  • An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
  • The anticipated salary range is $213,000 - $240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

Location: Hybrid - Waltham, MA or Menlo Park, CA. Candidates will be required to be in-office 3 days/week Open to remote for non-local candidates
We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.
Salary Range for the Role
$213,000-$240,000 USD
What We Offer:
  • A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
  • Competitive salary and benefits package.
  • A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
  • Opportunities for professional growth and development.

Apply