Associate Director, Computer System Assurance

You will lead the development of our technology policies, procedures, and work instructions focused on aligning processes with technical capabilities. You will own validation activities and ensure that our computer systems are compliant with appropriate regulations including 21 CFR Part 11. We will count on you to be forward thinking about the adoption of upcoming guidance on computer system assurance from the FDA. You will be a key member implementing and managing our Software Development Life Cycle (SDLC) strategy. You will be responsible for external audits of our computer systems ensuring any corrective actions are implemented. You will be responsible to our computer system validation budget. Working closely with the Quality team, you will help foster a culture of compliance across the company.

The Impact You Will Have

• You will build and lead the computer system assurance capabilities of a rapidly growing company planning to operate on an unprecedented scale. Effective use of technology is critical to our success and by ensuring compliance and validation you will have broad impact companywide.

Your Superpowers

• You bring 6+ years of experience in the biopharma or CRO industry in a strategic role related to computer system validation and compliance.
• You have extensive knowledge of Computer System Validation in FDA regulated environment.
• You stay up to date with the everchanging regulatory landscape related to compliance and validation.
• You are passionate about standards and best practices to drive consistency and efficiency.
• You have represented IT in support of regulatory audits.
• Knowledge of data privacy regulations (e.g. GDPR) is a plus.
• You thrive in a collaborative environment and can effectively communicate with internal teams, strategic partners, and vendors.
• You flourish in a smaller company environment and love the pace of a true startup.
• You're a team player who is willing to roll-up your sleeves and get the job done.
• Job Code: #LI-JR1

EQRx is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.