Celebrating 40+ years!

Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.

As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

Location: Remote US

The Manager, Validation & Testing leads Computer Systems Validation (CSV), software quality assurance, and testing for GxP and non-GxP systems. Approximately 50% of the role focuses on designing, implementing, and scaling automated testing to transition the organization from primarily manual testing to a modern, reusable framework. The role also ensures applicable computerized systems comply with GxP, GAMP 5, 21 CFR Part 11, ALCOA+, internal procedures, and other regulatory requirements. This position establishes validation and testing standards that improve quality, efficiency, and audit readiness across the application portfolio.

The position collaborates with business stakeholders, developers, infrastructure teams, project managers, Quality Assurance, and regulatory personnel to deliver and maintain reliable systems that meet applicable business, quality, and compliance requirements.

Key Responsibilities

Test Automation

• Lead the automation testing strategy for GxP and non-GxP systems, including the transition from manual testing to scalable, risk-based automated testing.
• Evaluate, select, implement, and maintain tools and frameworks for functional, integration, regression, performance, API, data, and user acceptance testing.
• Establish automation standards, coding practices, reusable test components, and test data approaches to improve consistency, coverage, and maintainability.
• Integrate automated testing into SDLC and CI/CD processes to support reliable and efficient software releases.
• Identify and prioritize automation opportunities based on business value, system risk, test frequency, and expected efficiency gains.
• Define and monitor metrics for automation coverage, execution efficiency, defect detection, and test reliability.
• Ensure automated test solutions used as GxP evidence are appropriately controlled, documented, versioned, reviewed, and capable of producing complete and reliable execution evidence.

Validation and Compliance

• Lead risk-based validation for GxP applications, cloud platforms, databases, integrations, and reporting systems in accordance with applicable regulations, industry guidance, and internal procedures.
• Create, review, and approve validation deliverables, including validation plans, risk assessments, traceability matrices, IQ/OQ/PQ protocols, test plans, test scripts, and validation summary reports.
• Assess changes to determine validation impact and required testing for system enhancements and releases.
• Manage validation deviations, root cause analyses, and corrective and preventive actions, as applicable.
• Ensure validation and testing strategies address role-based access, segregation of duties, electronic records and signatures, audit-trail functionality, data integrity, and authorized review of audit information.
• Maintain inspection and audit readiness and support internal, sponsor, and regulatory audits.

Quality Assurance and Testing

• Oversee manual and automated functional, integration, regression, performance, security, data, and user acceptance testing for GxP and non-GxP systems.
• Ensure test coverage is traceable to applicable business, functional, technical, quality, and regulatory requirements.
• Review and approve test plans, scripts, evidence, results, and related validation documentation.
• Establish testing templates, defect management practices, metrics, and reporting processes.
• Partner with development and business teams to investigate defects, resolve issues, and support timely releases.

Team Leadership and Process Improvement

• Lead, mentor, and develop validation and testing personnel, including training on CSV, GxP compliance, test automation, and quality practices.
• Allocate resources, manage priorities, and oversee the timely delivery of validation and testing activities.
• Drive continuous improvement across validation, testing, and quality assurance processes without compromising applicable compliance requirements.
• Develop and maintain validation, testing, SDLC, and related procedures and standards.
• Ensure validation and testing records are complete, approved, consistently identified, retained in approved repositories, readily retrievable, and suitable to support inspections and audits.

Level of Education

• Bachelor’s degree required. Advanced degree preferred.

Prior Experience

• 8+ years of experience in Computer Systems Validation (CSV) and software testing.
• 5+ years of experience leading or managing validation, quality assurance, or testing teams.
• Experience in pharmaceutical, biotechnology, CRO, medical device, or other regulated environments.
• Demonstrated experience designing, implementing, and scaling automated testing frameworks.
• Experience with relational databases including SQL Server and Oracle.

Skills and Competencies

• Strong knowledge of:
  • GxP
  • GAMP 5
  • 21 CFR Part 11
  • ALCOA+
• Risk-based validation methodologies
• Strong understanding of SDLC and Agile development methodologies
• Ability to understand system integration logic
• Ability to communicate technical and testing issues clearly with developers and stakeholders
• Ability to manage competing priorities in a fast-paced environment
• Strong analytical and problem-solving skills
• Strong attention to detail and commitment to high-quality results
• Excellent interpersonal and written and verbal communication skills
• Highly organized and results-oriented
• Ability to work independently, remotely, and collaborative

What We Offer

At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $130,000 - $165,000. The actual salary offer will be based on a number of factors, including but not limited to the candidate’s qualifications, experience, skills, and competencies for the role.

This position is not eligible for relocation or company provided sponsorship.

Theradex is an Equal Opportunity Employer.