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Computerized Systems Validation and QA Lead

IL | Full-time

About Dot Compliance

Dot Compliance provides a ready-to-deploy, Salesforce-native eQMS with the industry’s first AI specifically built to deliver safe, reliable decision guidance for critical quality issues. This offers faster, more proactive quality and compliance through vertical AI that empowers data-driven decision making in life sciences quality and compliance.

 

The company’s solutions are trusted by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001.

Who we’re looking for

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.

Do you have what we’re looking for?

  • 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.

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