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Director Quality Systems Jobs in Oregon (NOW HIRING)

Lonza

Associate Director, Quality Assurance

Bend, OR · On-site

You will play a critical role in ensuring compliance, strengthening quality systems, and supporting the delivery of life-changing therapies. This is a fully site-based role. Working together in ...

Lonza

Associate Director, Quality Assurance

Bend, OR · On-site

You will play a critical role in ensuring compliance, strengthening quality systems, and supporting the delivery of life-changing therapies. This is a fully site-based role. Working together in ...

AllCare Health, Inc.

QUALITY DIRECTOR

Grants Pass, OR · On-site

$100 - $120/hr

Title Quality Director - Quality Department Summary This position is responsible for maintaining an ... Utilize tools and systems for Continuous Quality Improvement, including analysis and interpretation ...

Orenco Systems

Quality Manager

Sutherlin, OR · On-site

$115K - $130K/yr

... systems, Control Panels) meet or exceed customers' requirements. This position interfaces with ... This position is responsible for directing Quality Analysts and quality auditors in support of ...

Orenco Systems

Quality Manager

Sutherlin, OR

... systems, Control Panels) meet or exceed customers' requirements. This position interfaces with ... This position is responsible for directing Quality Analysts and quality auditors in support of ...

Orenco Systems

Quality Manager

Sutherlin, OR · On-site

$115K - $130K/yr

This position is responsible for directing Quality Analysts and quality auditors in support of ... systems. Implement corrective action plan. Prepare for and manage external audits. Utilize ...

Kanto Corporation

Director of Quality

Portland, OR · On-site

$160K - $190K/yr

If you thrive on building best-in-class quality systems, leading cross-functional change, and ... Oversee QA & QC * Direct all testing, inspection, and verification activities for high-purity ...

Telix Pharmaceuticals (AMER)

OR · On-site

Quality Systems and Process Improvement * Support the implementation and continuous improvement of ... Direct experience in radiopharmaceutical quality required, including familiarity with short half ...

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All JobsQuality Systems JobsDirector Quality Systems JobsDirector Quality Systems Jobs in Oregon

Director Quality Systems information

See Oregon salary details

$32.8K

$132.8K

$225.7K

How much do director quality systems jobs pay per year?

As of Aug 11, 2026, the average yearly pay for director quality systems in Oregon is $132,796.00, according to ZipRecruiter salary data. Most workers in this role earn between $96,200.00 and $159,600.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a director quality systems?

To thrive as a Director of Quality Systems, you need deep expertise in quality management principles, regulatory compliance, process improvement, and typically a relevant degree such as in engineering or life sciences. Familiarity with quality management systems (QMS) like ISO 9001, FDA regulations, and proficiency with tools such as CAPA, risk management software, and internal audit systems is essential. Strong leadership, strategic thinking, and effective communication distinguish top performers in this role. These skills ensure the organization maintains high quality standards, meets regulatory requirements, and drives continuous improvement across all operations.

What are some common challenges faced by a director quality systems when implementing new compliance standards across an organization?

A Director of Quality Systems often encounters challenges such as resistance to change from staff, alignment of existing processes with new regulatory requirements, and ensuring consistent training across departments. Effective communication and cross-functional collaboration are key to overcoming these hurdles. The role typically involves working closely with leadership, operations, and regulatory teams to ensure that new standards are understood and integrated smoothly, minimizing disruptions while maintaining compliance.

What is a director quality systems?

A Director of Quality Systems is a senior management professional responsible for overseeing the development, implementation, and maintenance of an organization's quality management systems. They ensure that products and processes comply with industry standards, regulatory requirements, and company policies. This role often involves leading teams, developing quality strategies, conducting audits, and driving continuous improvement initiatives across the organization. Directors of Quality Systems play a critical part in safeguarding product quality, customer satisfaction, and regulatory compliance.

What is the difference between Director Quality Systems vs Quality Manager?

AspectDirector Quality SystemsQuality Manager
ResponsibilitiesOversees quality systems, compliance, and strategic quality initiatives across departmentsManages daily quality operations, audits, and team supervision
CertificationsISO 9001 Lead Auditor, CQE, Six SigmaISO 9001 Lead Auditor, CQE, Six Sigma
Work EnvironmentStrategic planning, cross-departmental collaborationOperational focus, team management
Industry UsageCommon in regulated industries like pharmaceuticals, medical devicesWidely used in manufacturing, production facilities

The main difference between a Director Quality Systems and a Quality Manager lies in scope and strategic focus. The Director typically oversees the entire quality system, ensuring compliance and strategic alignment, while the Quality Manager handles daily quality operations and team supervision. Both roles often require similar certifications and work in regulated industries, but the Director's role is more strategic and cross-departmental.

What are the most commonly searched types of Quality Systems jobs in Oregon? The most popular types of Quality Systems jobs in Oregon are:
What are popular job titles related to Director Quality Systems jobs in Oregon? For Director Quality Systems jobs in Oregon, the most frequently searched job titles are:
What job categories do people searching Director Quality Systems jobs in Oregon look for? The top searched job categories for Director Quality Systems jobs in Oregon are:
What cities in Oregon are hiring for Director Quality Systems jobs? Cities in Oregon with the most Director Quality Systems job openings:
Director Quality Systems jobs near you
Infographic showing various Director Quality Systems job openings in Oregon as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 15% Part Time, 4% Contract, and 1% Nights. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $132,796 per year, or $63.8 per hour.

Director, Quality Engineering & Computer System Assurance

Serán BioScience

Bend, OR • On-site

Full-time

PTO

Re-posted 25 days ago

Job description

Serán 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:
Serán 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. Serán 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 Serán 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 and identifying potential inconsistencies or verification signals in application materials based on available information. 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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