Program Manager - AI Transformation in Life Sciences Testing & Validation

As a Program Manager - AI Transformation in Life Sciences Testing & Validation, you will make an impact by leading enterprise-scale testing and validation programs across pharmaceutical and life sciences organizations. You will be a valued member of the Quality Engineering & Assurance team and work collaboratively with business stakeholders, regulatory teams, project leaders, validation specialists, and technology partners to ensure high-quality, compliant, and audit-ready solutions.

Lead end-to-end testing and validation programs across multiple systems and work streams, ensuring alignment with quality, compliance, and business objectives.

Develop and execute validation and testing strategies supporting regulated environments, digital transformation initiatives, and Computer Software Assurance (CSA) adoption.

Drive governance, stakeholder engagement, risk management, and program reporting to ensure successful delivery of testing outcomes.

Guide the adoption of test automation, AI-enabled testing, and modern quality engineering practices while maintaining compliance with GxP regulations and validation standards.

Partner with business, quality, and regulatory stakeholders to ensure systems supporting clinical, regulatory, manufacturing, and digital operations remain compliant, validated, and audit-ready.

We strive to provide flexibility wherever possible. Based on this role’s business requirements, this is a Remote position open to qualified applicants in the United States . Regardless of your working arrangement, we are here to support a healthy work-life balance through our various wellbeing programs.

The working arrangements for this role are accurate as of the date of posting. This may change based on the project you're engaged in, as well as business and client requirements. Rest assured, we will always be clear about role expectations .

15+ years of experience in Testing, Quality Engineering, and Validatio n within the pharmaceutical or life sciences industry, including 5+ years in leadership or management roles.

Deep expertise in Computer System Validation (CSV) ,
Computer Software Assurance (CSA), GxP regulations, FDA and EMA requirements, 21 CFR Part 11, and GAMP 5.

Proven experience leading large-scale testing and validation programs across clinical, regulatory, manufacturing, quality, or digital platforms in regulated environments.

Strong stakeholder management, governance, risk management, resource planning, and project delivery experience.

Knowledge of ALM/Test Management tools and experience supporting digital transformation initiatives.

Experience validating AI/ML-enabled solutions with consideration for model accuracy, bias, explainability, drift, and revalidation requirements.

Experience defining risk-based testing and validation strategies for commercial off-the-shelf (COTS), configured, and customized systems.

Excellent communication, leadership, and executive reporting skills with the ability to influence cross-functional stakeholders.

Bachelor’s degree in computer science, Life Sciences, Engineering, or a related field.

Experience implementing or driving Computer Software Assurance (CSA) transformations within pharmaceutical organizations.

Exposure to test automation frameworks and quality engineering practices in regulated environments.

Knowledge of AI-enabled testing capabilities, including AI-assisted test design, self-healing automation, and defect prediction technologies.

Certifications such as PMP, ISTQB, or relevant Quality, Validation, or Regulatory Compliance credentials.

Advanced degree in Life Sciences, Engineering, Computer Science, or a related discipline.

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