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Program Integrity Director Jobs in Oregon (NOW HIRING)

Hearts With A Mission

Program Coordinator

Newport, OR · On-site

$50K - $60K/yr

Provide regular program updates to HWAM Regional Director, CEO & CPO as requested. * Participate in ... Must demonstrate a high degree of personal initiative and integrity. * Must be flexible and adapt ...

Emerus

... the integrity, scalability, and reliability of data systems. The Director enables data-driven ... Support configuration and implementation of new survey programs for new hospital openings ...

REAP INC

Director of Development

Eagle Creek, OR · On-site

... program. • Foster a culture of collaboration, innovation, and accountability within the ... Demonstrates integrity and strong values through consistent action. • Emotional intelligence ...

Posted today

Shrinerschildrens

Director, Rehab - PT

Portland, OR

$130K - $195K/yr

Our compassion, integrity, accountability, and resilience define us as leaders in pediatric ... Leads program development to best serve intended populations, effectively and efficientlyand be a ...

Work Unlimited

Residential Program Manager

Salem, OR · On-site

$3.6K - $4.2K/mo

We are hiring a Residential Program Manager to guide a team of direct support professionals in providing trauma-informed, youth-centered care. If you're ready to lead with integrity, build staff ...

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All JobsProgram Integrity JobsProgram Integrity Director JobsProgram Integrity Director Jobs in Oregon

Program Integrity Director information

What are the key skills and qualifications needed to thrive as a Program Integrity Director, and why are they important?

To thrive as a Program Integrity Director, you need expertise in compliance, risk management, regulatory analysis, and a relevant degree such as in business administration, public policy, or law. Familiarity with data analytics tools, case management systems, and certifications like Certified Fraud Examiner (CFE) or Certified Internal Auditor (CIA) are often important. Strong leadership, ethical judgment, and effective communication skills are crucial for building trust and guiding teams through complex investigations. These skills ensure the organization maintains regulatory compliance, prevents fraud, and promotes operational transparency.

What is the difference between Program Integrity Director vs Claims Manager?

AspectProgram Integrity DirectorClaims Manager
Required CredentialsBachelor's degree, certifications in healthcare compliance or auditingBachelor's degree, experience in claims processing or insurance
Work EnvironmentHealthcare or insurance organizations, compliance departmentsInsurance companies, healthcare payers, claims processing units
Employer & Industry UsageUsed in healthcare, government programs, insurance sectorsPrimarily in insurance companies and healthcare payers

The Program Integrity Director focuses on ensuring compliance, preventing fraud, and maintaining program integrity within healthcare or insurance organizations. In contrast, Claims Managers oversee the processing and adjudication of insurance claims. While both roles require knowledge of healthcare or insurance operations, the Program Integrity Director emphasizes compliance and fraud prevention, whereas the Claims Manager concentrates on claims processing efficiency and accuracy.

What are Program Integrity Directors?

Program Integrity Directors are responsible for overseeing and ensuring the compliance, effectiveness, and accountability of organizational programs, often within government agencies or large organizations. They develop and implement policies to prevent fraud, waste, and abuse, and they monitor program operations to ensure adherence to regulations and standards. Program Integrity Directors often lead teams, conduct audits, and collaborate with other departments to promote transparency and ethical practices. Their work is crucial for maintaining public trust and ensuring resources are used appropriately.

What are some typical challenges faced by a Program Integrity Director, and how can they be addressed?

Program Integrity Directors often face challenges such as navigating complex regulatory requirements, detecting and preventing fraud, and ensuring compliance across multiple departments or partners. Addressing these requires strong analytical skills, clear communication, and effective collaboration with legal, compliance, and operational teams. Staying updated on industry best practices and fostering a culture of transparency can also help mitigate risks and support program goals.
What are popular job titles related to Program Integrity Director jobs in Oregon? For Program Integrity Director jobs in Oregon, the most frequently searched job titles are:
What job categories do people searching Program Integrity Director jobs in Oregon look for? The top searched job categories for Program Integrity Director jobs in Oregon are:
What cities in Oregon are hiring for Program Integrity Director jobs? Cities in Oregon with the most Program Integrity Director job openings:
Program Integrity Director jobs near you
Director, Quality Engineering & Computer System Assurance

Director, Quality Engineering & Computer System Assurance

Serán BioScience

Bend, OR • On-site

Full-time

Re-posted 5 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.