Manager, Validation & Testing

Theradex Oncology•Princeton, NJ

2d•$130,000 - $165,000•Remote

About The Position

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 position ensures applicable computerized systems comply with GxP, GAMP 5, 21 CFR Part 11, ALCOA+, internal procedures, and other regulatory requirements, and 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 business, quality, and compliance requirements. It is a remote US role at Theradex Oncology, a full-service CRO specializing in oncology trials and programs for domestic and international sponsors.

Requirements

Bachelor’s degree required.
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.
Strong knowledge of GxP, GAMP 5, 21 CFR Part 11, ALCOA+, and 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, written, and verbal communication skills.
Highly organized and results-oriented.
Ability to work independently, remotely, and collaboratively.

Nice To Haves

Advanced degree preferred.

Responsibilities

Lead the automation testing strategy for GxP and non-GxP systems, including transitioning 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.
Integrate automated testing into SDLC and CI/CD processes.
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 controlled, documented, versioned, reviewed, and capable of producing complete and reliable execution evidence.
Lead risk-based validation for GxP applications, cloud platforms, databases, integrations, and reporting systems in accordance with regulations, industry guidance, and internal procedures.
Create, review, and approve 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.
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.
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 timely delivery of validation and testing activities.
Drive continuous improvement across validation, testing, and quality assurance processes without compromising 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.