Director, Computer System Validation - Quality Assurance (CSV QA)

Position Overview

• Location Type: Remote
• Employment Type: Full-time
• Salary: Not specified

About Apogee Therapeutics:

Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed biotechnology company founded in 2022. It is seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications with high unmet need. Apogee is committed to building an exceptional company culture based on its C.O.R.E. values: Caring, Original, Resilient, and Egoless.

Role Summary

Apogee Therapeutics is seeking a Director of Computer System Validation (CSV) Quality Assurance (QA) to provide strategic leadership and oversight of the validation of GXP computer systems and software. This role will drive the development, execution, and continuous improvement of CSV and Computer Software Assurance (CSA) processes, ensuring systems are validated, maintained, and compliant with regulatory standards.

Key Responsibilities

• Lead and manage the CSV QA function, ensuring GXP computer systems are validated in compliance with relevant regulatory requirements.
• Develop and implement CSV strategies, policies, and processes to ensure consistent, scalable, and efficient validation across the organization.
• Oversee the planning, execution, and documentation of validation activities for new and existing GXP computer systems, ensuring compliance throughout their software development lifecycle (SDLC).
• Collaborate cross-functionally with IT, software development, regulatory affairs, and other departments to ensure seamless integration of validated systems into business operations.
• Lead efforts to identify, assess, and mitigate risks related to computer systems, ensuring potential issues are proactively addressed.
• Drive improvements in CSV and data integrity processes and methodologies, introducing innovative solutions and best practices, including CSA principles, to enhance efficiency and ensure scalability.
• Ensure validation documentation (validation plans, test scripts, reports, risk assessments, etc.) is maintained in compliance with regulatory requirements.

Requirements

• (No specific requirements listed in the provided text)

Application Instructions

• (No application instructions provided in the text)