Associate Director, GxP R&D Systems - Remote

Overview

We are seeking an Associate Director, GxP R&D Systems to lead our efforts in supporting Quality, Regulatory, Clinical, Medical Affairs, and Biometrics teams. This role will focus on developing and maintaining an integrated system landscape for our GxP environment, ensuring seamless data flow and compliance across functions.

In Short

• Lead efforts in supporting Quality, Regulatory, Clinical, Medical Affairs, and Biometrics teams.
• Develop and maintain an integrated system landscape for GxP environment.
• Architect solutions that support clinical and regulatory operations.
• Administer and maintain GxP systems for reliability and compliance.
• Design and implement solutions for various teams.
• Lead integration efforts across GxP systems.
• Ensure data integrity and compliance for R&D systems.
• Foster a collaborative and high-performing IT team.
• Provide mentorship and guidance to team members.
• Manage multiple complex projects effectively.

Requirements

• 8+ years of experience in systems architecture or integration in biotech.
• Expertise in GxP system integration and middleware tools.
• Experience with clinical, quality, and regulatory systems.
• Strong understanding of GxP requirements and data integrity.
• Proven ability to manage complex projects.
• Strong leadership skills with a growth mindset.
• Ability to travel 10 – 15%.

Benefits

• Great culture grounded in C.O.R.E. values.
• Opportunity to work in a fast-paced environment.
• Market competitive compensation and benefits package.
• Flexible PTO.
• Two company-wide shutdowns each year.
• Commitment to professional growth and development.
• Regular in-person team meetings.