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Life Science Qa Test Program Manager - Associate Director

15+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Test Program Manager – Life Science (Pharma Testing & Validation)
Company: Cognizant Technology Solutions

Location:

  • Remote, with travel required for client engagements as needed

Overview:
Cognizant is seeking a highly skilled Test Program Manager – Life Science who will oversee Pharma Testing & Validation engagements, ensuring compliance with industry regulations and supporting digital transformation initiatives. If you are passionate about driving change in the pharmaceutical domain through innovation and collaboration, this is an exciting opportunity for you.

Key Responsibilities:

  • Develop and implement Validation and Test strategies that align with regulatory requirements (FDA, EMA, GxP standards), supporting the transition to CSA (Computer Software Assurance).
  • Identify new opportunities and collaborate with key stakeholders to showcase testing and validation capabilities.
  • Lead the transition from paper-based systems to ALM/Test management tools, ensuring compliance with regulatory requirements.
  • Manage end-to-end Validation and Testing for systems supporting drug development, clinical data management, regulatory submissions, and digital documentation.
  • Ensure compliance with regulations such as 21 CFR Part 11, GAMP (Good Automated Manufacturing Practices), and other related standards.
  • Define and execute test scripts to ensure systems meet GxP and CSV/CSA standards and are audit-ready.
  • Act as the primary liaison between QA, regulatory, and business teams, ensuring smooth communication and providing regular updates on testing progress.
  • Lead risk-based testing efforts to mitigate compliance risks across pharmaceutical applications.
  • Identify opportunities for test automation and work with architects and automation specialists to implement automation frameworks.

Required Skills/Qualifications:

  • 15+ years of experience in Testing & Validation within the pharmaceutical or life sciences domain, with at least 5+ years in a management role.
  • Expertise in CSV (Computer System Validation) and CSA (Computer Software Assurance) processes.
  • Strong understanding of FDA, EMA, GxP, and 21 CFR Part 11 regulatory requirements.
  • Experience with ALM/Test management tools and exposure to test automation frameworks.
  • Proven experience in project management, handling complex test programs and resource allocation.
  • Excellent communication and reporting skills, including the ability to prepare clear reports and conduct stakeholder meetings effectively.
  • Bachelor’s degree in computer science, Life Sciences, or a related field; advanced degree preferred.
  • Certifications (optional): ISTQB, PMP, or relevant regulatory compliance certifications.

Other Information:

  • This role requires someone who thrives in an autonomous work environment and enjoys navigating ambiguity.
  • The home office setup (network, phone, etc.) is flexible, and the role involves travel for client engagements as needed.
  • The ideal candidate will have a collaborative mindset, working effectively across cross-functional teams to achieve shared goals.

About Cognizant:

  • Cognizant is a leading global professional services company, helping clients transform their business, operations, and technology models for the digital age. Headquartered in the U.S., Cognizant is recognized for its innovative solutions and inclusive work culture.
  • The company is committed to diversity and inclusion, offering an environment where all employees feel valued and supported.

Apply today if you’re looking to lead innovation in pharma testing and validation and be part of a dynamic, global team!

Disclaimer:
Compensation information is accurate as of the posting date. Cognizant reserves the right to modify this information in accordance with applicable laws.