Life Science QA Test Program Manager - Associate Director

Cognizant Technology Solutions - Boston, MA

Full-time - Senior

Boston, MA

Professional, Scientific, and Technical Services

About the position

The Life Science QA Test Program Manager - Associate Director at Cognizant is responsible for overseeing the project delivery of Pharma Testing & Validation engagements. This role involves developing and implementing validation and test strategies that align with regulatory requirements, managing end-to-end validation phases, and ensuring compliance with industry regulations. The position requires strong leadership skills to collaborate with various stakeholders and drive continuous improvement in testing processes.

Responsibilities

• Develop and implement comprehensive Validation and Test strategies aligned with regulatory requirements such as FDA, EMA, and GxP standards.
• Identify new areas for penetration and partner with key stakeholders to showcase testing and validation capabilities.
• Define objectives and priorities for Validation and testing activities across clinical, regulatory, and manufacturing systems.
• Collaborate with project stakeholders to establish Validation and testing protocols and ensure adherence to CSV/CSA principles.
• Manage end-to-end Validation and test phases for systems supporting drug development and regulatory submissions.
• Ensure compliance with industry regulations, including 21 CFR Part 11, focusing on Good Automated Manufacturing Practices (GAMP).
• Lead risk-based Validation and testing efforts to mitigate compliance risks across applications.
• Define standards to design and execute Validation and test scripts that confirm systems meet GxP and CSV/CSA standards.
• Maintain detailed documentation of test results, issues, and resolutions to support regulatory audits.
• Identify opportunities for Test automation and work with Architects and Automation specialists to implement.
• Continuously review and refine testing processes to improve productivity, quality, and compliance.
• Act as the primary liaison between QA, regulatory, and business teams, providing regular updates on testing progress.
• Prepare comprehensive reports on Validation and testing activities, including transformation progress.
• Lead regular meetings with stakeholders to discuss Validation and testing plans and opportunities for continuous improvement.

Requirements

• 15+ years of experience in Testing & Validation within the pharmaceutical or life sciences domain.
• 5+ years in a management role.
• In-depth knowledge of Computer System Validation (CSV) and Computer Software Assurance (CSA) processes.
• Strong understanding of FDA, EMA, GxP, and 21 CFR Part 11 requirements.
• Experience with GAMP and validation processes.
• Exposure to test automation frameworks.
• Solid project management skills, with the ability to manage complex test programs.
• Demonstrated success in working with diverse teams, including QA, regulatory, and business stakeholders.
• Excellent written and verbal communication skills.

Nice-to-haves

• ISTQB Certification
• PMP Certification
• Advanced degree in computer science, Life Sciences, or a related field.

Benefits

• Home office setup (network, phone, etc.)