Lead CSV/CSA Lead

For our client, we are seeking a Lead CSV/CSA Lead to join the team of a leader in the Healthcare space.

In this role, you will lead validation and assurance efforts for new systems and changes within a regulated healthcare environment. You will own the validation lifecycle from planning through documentation, helping ensure that critical systems meet GxP, CSV, CSA, and data integrity expectations. This position also partners closely with cross-functional stakeholders and helps strengthen validation practices through mentoring and continuous improvement.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $130,000 – $155,000 annually

Responsibilities

• Lead validation and assurance planning for new systems and changes
• Author and oversee validation lifecycle deliverables
• Ensure compliance with GxP and regulatory standards
• Manage lifecycle documentation and change impact assessments
• Mentor junior team members on validation principles
• Facilitate cross-functional communication regarding validation strategy

Qualifications

• Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or a related field
• 7+ years of experience in CSV/CSA, GxP IT quality, validation, or regulated system lifecycle
• Strong knowledge of CSV, CSA, GAMP 5, SDLC, and data integrity
• Experience leading validation strategy for complex systems
• Proficient in technical writing and documentation review
• Ability to work independently and prioritize tasks

Benefits

• Remote work flexibility with East Coast preference
• Opportunity for professional development and mentoring
• Engagement in complex and impactful projects
• Collaboration with cross-functional teams
• Support for continuous improvement initiatives

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.