Computerized Systems Validation and QA Lead

Dot Compliance empowers life sciences organizations to deliver life-saving products faster, safer, and more efficiently, by providing them with innovative AI-powered SaaS solutions to manage their quality and compliance needs.

We are looking for a skilled and motivated CSV and QA Lead to join our Quality and Compliance team. This hybrid role combines Computerized Systems Validation (CSV) expertise with Quality Assurance (QA) support, and plays a critical part in ensuring that our software and internal systems meet applicable regulatory and industry standards.

Computerized Systems Validation (CSV):

• Lead and execute validation activities for GxP-regulated system in accordance with FDA 21 CFR Part 11 and EU Annex 11.
• Create, review, and maintain validation documentation (VP,URS, FRS, VSR).
• Plan ,Review and approve test protocols (e.g. OQ,PQ)
• Collaborate with software engineering, product, and QA teams to ensure validation requirements are integrated into development and testing.
• Responsible for quality validation product per each release
• Manage periodic reviews and revalidation processes as needed.
• Support internal and customer-facing QA processes, including audits, CAPA, change control, and documentation.
• Maintain compliance with relevant GxP guidelines and pharmaceutical regulatory requirements.
• Contribute to the development, improvement, and enforcement of SOPs and quality policies.
• Act as a liaison between IT and QA functions to ensure proper system implementation and ongoing compliance.

• 3+ years of experience in CSV within a GxP environment, preferably in life sciences or pharmaceutical industry.
• Solid understanding of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidance.
• Experience with Quality Management Systems (QMS) and document control.
• Knowledge of IT/QA interfaces, including infrastructure qualification and data integrity requirements.
• Strong analytical and organizational skills, with keen attention to detail.
• Excellent verbal and written communication skills in English.
• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field

Preferred Qualifications

• Experience in SaaS or software validation environment.
• Familiarity with Agile development processes.
• Exposure to customer audit support and regulatory inspections.