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Software Validation and QA Lead

Dot Compliance
Full-time
Remote
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.