ALM Validation Lead
Cognizant
**About the role**
As an **ALM** **Validation Lead** , you will make an impact by leading validation and testing initiatives across life sciences systems, ensuring compliance with global regulatory standards while driving digital transformation. You will be a valued member of the **Quality Engineering and Assurance** team and work collaboratively with cross-functional stakeholders including regulatory, compliance, and business teams.
**In this role, you will:**
+ Develop and implement comprehensive validation and test strategies aligned with FDA, EMA, and GxP standards, supporting the transition to CSA.
+ Define objectives and priorities for validation and testing across clinical, regulatory, and manufacturing systems, with a focus on digital transformation and paperless execution.
+ Lead end-to-end validation and testing phases for systems supporting drug development, clinical data management, regulatory submissions, and digital documentation.
+ Collaborate with stakeholders to establish validation protocols and ensure adherence to CSV/CSA principles.
+ Drive adoption and transition from paper-based processes to ALM/Test Management tools, ensuring regulatory compliance.
**Work model:**
We believe hybrid work is the way forward as we strive to provide flexibility wherever possible. Based on this role’s business requirements, this is a **hybrid position requiring 2–3 days a week onsite** in **Foster City, CA** . Regardless of your working arrangement, we are here to support a healthy work-life balance through our various wellbeing programs.
**What you need to have to be considered:**
+ 10+ years of experience in testing and validation within the pharmaceutical or life sciences domain, including 2+ years in a management role.
+ Expertise in Computer System Validation (CSV) and Computer Software Assurance (CSA).
+ Strong knowledge of ALM Test Management tools.
+ Deep understanding of FDA, EMA, GxP, and 21 CFR Part 11 requirements; familiarity with GAMP standards.
+ Solid project management skills with experience managing complex test programs and cross-functional teams.
+ Excellent communication and reporting skills, including stakeholder engagement and documentation for audits.
+ Bachelor’s degree in Computer Science, Life Sciences, or a related field; advanced degree preferred.
**These will help you stand out:**
+ Experience in Salesforce implementation and testing.
+ Exposure to test automation frameworks and tools.
+ Experience managing data testing initiatives including ETL, Data Warehousing, Data Lakes, Hadoop, and data transformation techniques.
+ Certifications such as ISTQB, PMP, or relevant regulatory compliance credentials.
+ Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship
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.
**_Salary and Other Compensation:_**
· The annual salary for this position is between [$71,100/- to $112,500/-] depending on experience and other qualifications of the successful candidate.
· This position is also eligible for Cognizant’s discretionary annual incentive program, based on performance and subject to the terms of Cognizant’s applicable plans.
**_Benefits:_**
· Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:
· 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
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Confirmar seu email: Enviar Email
Todos os Empregos de Cognizant