Remote Senior Specialist Quality Assurance, CSV

Description:

• Responsible for ensuring GxP systems are implemented, validated, and maintained in compliance with regulatory and quality standards.
• Collaborates with IT and business teams to support system lifecycle activities, including vendor evaluations and software implementation.

Requirements:

• 7+ years experience in the pharmaceutical/biotech industry required.
• 5+ years’ experience with CSV validation lifecycle management.
• Bachelor’s degree in a life science field.
• Strong understanding of 21 CFR Part 11 compliance, CSV, CSA, IT SDLC best practices, GDPR regulations, and GAMP 5 Guidance.
• Proven experience in validating SaaS/PaaS GxP systems.
• Broad understanding of technology implementation and data migration approaches.
• Experience with AI/ML-based systems in a regulated environment.
• Demonstrated experience in reviewing validation deliverables.

Benefits:

• 100% paid health benefits including Medical, Dental, and Vision for you and your dependents.
• 401(k) program with company match and vesting after the first month.
• Flexible time off.
• Generous parental leave and additional perks.