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$125.6K

$213.5K

How much do director quality engineering jobs pay per year?

As of Jun 8, 2026, the average yearly pay for director quality engineering 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 is the difference between Director Quality Engineering vs Quality Manager?

AspectDirector Quality EngineeringQuality Manager
ResponsibilitiesOversees quality engineering teams, develops quality strategies, and ensures product quality at a strategic level.Manages daily quality operations, implements quality control processes, and supervises quality staff.
Required CredentialsBachelor's or Master's in Engineering, Quality Management certifications (e.g., CQE), extensive industry experience.Bachelor's in related field, quality certifications (e.g., CQE, Six Sigma), relevant experience.
Work EnvironmentStrategic planning, cross-department collaboration, leadership roles in engineering teams.Operational focus, hands-on quality inspections, process implementation.

The main difference is that the Director of Quality Engineering focuses on strategic leadership and long-term quality initiatives, while the Quality Manager handles daily quality operations and process management. Both roles require similar credentials but differ in scope and focus within the quality management hierarchy.

What does a Director of Quality Engineering do?

A Director of Quality Engineering leads and manages the quality assurance and testing teams within an organization, establishing strategies, processes, and standards to ensure that products meet required quality benchmarks. They are responsible for developing quality engineering policies, overseeing testing efforts, and collaborating with cross-functional teams to improve product reliability and performance. This role often involves mentoring team members, implementing best practices, and driving continuous improvement initiatives to enhance quality across the organization.

How does a Director of Quality Engineering typically collaborate with cross-functional teams to drive quality initiatives?

A Director of Quality Engineering works closely with product management, development, operations, and customer support teams to ensure quality standards are embedded throughout the product lifecycle. This role often leads quality strategy discussions, sets up cross-team quality metrics, and facilitates regular meetings to address potential quality risks. Effective collaboration involves aligning testing processes with release schedules and ensuring feedback loops between engineering and quality assurance. Building strong partnerships across departments is crucial for proactively identifying issues and implementing continuous improvement initiatives.

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

To thrive as a Director of Quality Engineering, you need a strong background in quality assurance methodologies, leadership experience, and a relevant degree such as engineering or computer science. Familiarity with tools like Selenium, Jenkins, Jira, and knowledge of ISO or Six Sigma certifications are typically expected. Exceptional communication, strategic thinking, and team management skills help drive quality initiatives and foster a culture of continuous improvement. These skills are essential for ensuring product excellence, regulatory compliance, and operational efficiency within the organization.
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Director Quality Engineering jobs near you
Infographic showing various Director Quality Engineering job openings in the United States as of May 2026, with employment types broken down into 50% Full Time, and 50% Part Time. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution, with an average salary of $125,600 per year, or $60.4 per hour.

Director, Quality Engineering & Computer System Assurance

Seran BioScience

Bend, OR

Full-time

PTO

Posted 21 days ago

Job description

Seran BioScience seeks a Director, Quality Engineering & Computer System Assurance (CSA) to oversee and provide strategic and operational leadership for the organization's validation, qualification, and computerized systems assurance programs.  This role will support GMP manufacturing, laboratory, and quality systems that stretch across clinical and commercial operations.
 
This position is responsible for establishing and maintaining a risk-based validation and CSA framework ensuring that facilities, utilities, equipment, analytical methods, processes, and computerized systems remain in a validated state throughout their lifecycle. The Director, Quality Engineering & CSA ensures all validation and data integrity activities comply with FDA, EU, and international regulatory requirements, including cGMP, GAMP guidance, and current regulatory expectations for data integrity.
 
The role partners with Engineering, Manufacturing, Quality Control, IT, Regulatory Affairs, and Technical Operations to ensure validated systems and processes enable safe, compliant, and reliable manufacturing of clinical and commercial products. The Director, Quality Engineering & CSA also serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to validation lifecycle management, computerized system assurance, and data governance.
Duties and Responsibilities
Strategic Leadership
  • Develops and implements the site strategy for Quality Engineering and Computer System Assurance(CSA) programs
  • Supports the establishment governance structures for risk-based validation lifecycle management including planning, execution, maintenance, and periodic review
  • Leads initiatives to modernize validation practices including CSA adoption, digital validation approaches, and automation lifecycle management
  • Defines key performance indicators (KPIs) and metrics to measure effectiveness of QualityEngineering and CSA programs
  • Provides leadership to cross-functional teams supporting validation, qualification, and system lifecycle activitie
Validation Lifecycle Oversight
  • Provides Quality leadership and oversight of validation programs including:
    • Facility, utility, and equipment qualification, Cleaning validation, Computerized systems validation / assurance, & Manufacturing automation systems
Key activities include:
  • Approval and oversight of validation lifecycle documentation including: 
    • Validation Master Plans (VMP), User Requirement Specifications (URS), Functional and Design Specifications, Risk assessments, IQ/OQ/PQ protocols and reports, & Validation summary reports
  • Ensures validation activities comply with internal procedures and regulatory requirements and remain aligned with the site Validation Master Plan
  • Provides quality oversight for commissioning, qualification, and validation activities in highly automated manufacturing environments
  • Ensures validated systems maintain a continuous state of control throughout their operational lifecycle
Computer System Assurance (CSA) & Data Integrity
  • Supports the design and implementation of the organization's Computer System Assurance (CSA) and Computerized System Validation (CSV) programs
  • Ensures computerized systems comply with data integrity principles (ALCOA++) and regulatory expectations
  • Oversees validation lifecycle management for computerized systems including:
    • Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Quality management systems, Electronic Batch Record Systems, & Enterprise resource planning systems
  • Implements risk-based testing approaches consistent with GAMP 5 and modern CSA methodologies
  • Leads initiatives to strengthen enterprise data integrity governance programs across manufacturing, laboratory, and quality systems
  • Supports system lifecycle activities including system upgrades, migrations, and decommissioning
Operational Quality Engineering Support
  • Provides QA oversight and approval for quality system elements impacting validated systems including:
    • Change control processes impacting validated systems and processes, Deviation and investigation management, Corrective and Preventive Actions (CAPA), Risk management and impact assessments, & Periodic reviews of validated systems
  • Ensures that validation and CSA programs remain aligned with corporate policies, regulatory guidance, and evolving industry standards
  • Provides QA support for technology transfer, new product introductions, and site capital projects
  • Serves as the Quality Engineering representative for site project teams implementing new equipment, systems, or manufacturing technologies
  • Supports troubleshooting of complex process or system issues impacting validated systems
  • Serve as subject matter expert for validation, computerized systems assurance, and data integrity during regulatory inspections and Client audits
  • Leads preparation and inspection readiness programs related to validation and data integrity
Leadership & People Management
  • Leads and develops a high-performing Quality Engineering and CSA organization
  • Provides mentoring, coaching, and professional development for technical staff
  • Establish clear departmental goals aligned with organizational quality and operational objectives
  • Conducts performance reviews and ensure staff maintain appropriate training and GMP qualifications
  • Fosters a culture of quality ownership, compliance, and continuous improvement
Required Knowledge and Skills
  • Broad knowledge of FDA and international regulations related to GMPs and Pharmaceuticals
  • Experience organizing and managing work responsibilities while working independently with minimal oversight
  • Deep expertise in Computer System Validation / Computer System Assurance
  • Validation lifecycle management, Data integrity regulations and industry guidance, Risk-based validation methodologies
  • Time and project management skills with the ability to multi-task and meet deadlines
  • Excellent verbal and written communication skills
  • Excellent interpersonal and customer service skills
  • Excellent organizational skills and attention to detail
  • Strong analytical and problem-solving skills
  • Strong supervisory and leadership skills
  • Ability to prioritize tasks and to delegate them when appropriate
  • Willingness to accept feedback from a variety of sources
  • Ability to constructively manage conflict
  • Ability to collaborate and work in cross-functional teams
  • Ability to function well in a high-paced and at times stressful environment
  • Ability to maintain productive relationships with coworkers, clients, and other contacts outside the company
  • Proficient with Microsoft Office Suite or related software
Education and Experience
  • Bachelor's degree, preferably in a scientific discipline. Preference will be given to those with an advanced degree 
  • Minimum of 10+ years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industry
  • Minimum of 5+ years previous experience with qualification/validation/CSA activities in a QA or Technical capacity
  • Demonstrated experience with regulatory inspections by the FDA and EU authorities
Physical Requirements
  • Prolonged periods of sitting or standing at a desk and working on a computer
  • Must be able to lift up to 15 pounds at times
  • Adheres to consistent and predictable in-person attendance 
Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
 
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
 
Benefits Summary:
Seran employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Seran covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees' wellbeing, along with access to pet insurance.
 
The Corporate Headquarters of Seran BioScience are located at 63047 Layton Ave, Bend, OR 97701
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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