Job Description
Job Description
Who Our Client Is
Our client is a mission-driven organization focused on delivering high-quality, compliant solutions in a regulated environment. They value collaboration, accountability, and continuous improvement.
What Our Client Needs
An IT Senior Manager, Validated Systems to lead and support computer system validation activities and ensure ongoing compliance across critical business systems.
Who You Are
You are a hands-on IT senior leader with deep expertise in computer system validation. You work independently, exercise sound judgment, and communicate effectively with technical teams, quality partners, and business stakeholders. You bring a strong commitment to data integrity, compliance, and maintaining audit-ready validated systems.
What You’ll Do
- Own and oversee validated applications across multiple functional areas.
- Manage relationships with software vendors and service providers.
- Lead and support computer system validation activities in GxP environments.
- Author, review, and maintain validation documentation including URS, FRS, VPP, IQ, OQ, PQ, traceability matrices, and summary reports.
- Develop and execute test scripts and capture validation evidence.
- Manage deviations and support UAT and QA reviews.
- Ensure system changes follow change control and maintain validated state.
- Maintain audit readiness and support inspections.
- Partner with business stakeholders to optimize existing systems and identify new capabilities.
What You’ll Need
- Bachelor’s degree in Computer Science, Information Technology, or equivalent practical experience.
- 5+ years of validation experience in pharmaceutical, biotech, or medical device environments.
- At least 5 years of hands-on experience with Veeva Vault RIM (Submissions and Archive).
- Experience with LMS and Quality Management Systems.
- Strong knowledge of CSV regulations and standards including GAMP 5 and 21 CFR Part 11.
- Experience supporting audits and inspections.
- Experience with integration testing, data migration, and data quality validation.
- Strong analytical, problem-solving, and communication skills.
- High attention to detail and commitment to quality.
What They Offer
- Opportunities for professional development and career growth
- Collaborative and innovative work environment
- Medical, Dental, and Vision Insurance
- Life and AD&D Insurance
- Short- and Long-Term Disability Coverage
- 401(k) with generous company match
- Health Savings Account (HSA) and Flexible Spending Account (FSA) with company match
- Wellness Program and Employee Assistance Program (EAP)
- Generous Paid Time Off (PTO)
Equal Opportunity Statement
Our client believes that diversity fuels innovation, strengthens teams, and drives success. They are committed to fostering a workplace where every individual—regardless of background—feels valued, respected, and empowered to thrive. Discrimination or harassment of any kind is strictly prohibited.
Our client does not discriminate based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by applicable laws. Their commitment extends beyond compliance; they actively cultivate an inclusive culture where diverse perspectives are welcomed, and every employee has an equal opportunity to contribute and succeed.