QA Manager, CSV

​QA Manager, CSV

Remote

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We are seeking a Quality Assurance (QA) Manager – GXP Computer Systems to join a nonprofit social welfare entity with over 6 years in the industry, born out of the need to address the critical shortage of essential injectable medications in the U.S. healthcare system. Now they are dedicated to the development and manufacture of Insulin to create a more affordable and accessible healthcare system. This remote position will be key in ensuring the quality and compliance of our computerized systems, including overseeing the Computerized System Validation (CSV) for various platforms.

Responsibilities:

• Lead QA efforts for GXP computerized systems, ensuring compliance with regulatory standards.

• Oversee software validation and readiness for audits and inspections.

• Review proposed changes and conduct risk assessments to maintain compliance.

• Approve validation plans and reports, ensuring data integrity.

• Support external audits and provide guidance on GXP procedures.

• Collaborate with various teams to prioritize and implement system changes.

If you are looking to join an organisation with a dedication to accessible healthcare, who are currently expanding across the US to provide exciting growth opportunities - get in contact!