Note: The job is a remote job and is open to candidates in USA. Cognizant is seeking a Program Manager to lead enterprise-scale testing and validation programs for pharmaceutical and life sciences organizations. The role develops validation strategies, drives governance and stakeholder engagement, manages risk and reporting, and guides AI-enabled testing and quality engineering practices while ensuring compliance with GxP regulations and validation standards.
Responsibilities
- Lead end-to-end testing and validation programs across multiple systems and workstreams, 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
Skills
- 15+ years of experience in Testing, Quality Engineering, and Validation 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
- Remote position open to qualified applicants in the United States
- We're excited to meet people who share our mission and can make an impact in a variety of ways. Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role
- Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship
- Please note, this role is not able to offer visa transfer or sponsorship now or in the future
- 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
- Experience supporting the transition from paper-based validation processes to digital ALM and test management platforms
Benefits
- Cognizant’s discretionary annual incentive program, based on performance and subject to the terms of Cognizant’s applicable plans.
- Medical/Dental/Vision/Life Insurance
- Paid holidays plus Paid Time Off
- 401(k) plan and contributions
- Long-term/Short-term Disability
- Paid Parental Leave
- Employee Stock Purchase Plan
- Remote position open to qualified applicants in the United States
- Various wellbeing programs
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