Associate Director, GxP R&D Systems

Summary

Join Apogee Therapeutics, a fast-growing biotechnology company, as an Associate Director, GxP R&D Systems. Lead efforts in supporting various teams by developing and maintaining an integrated system landscape for the GxP environment. You will architect solutions supporting clinical and regulatory operations, ensuring seamless data flow and compliance. The ideal candidate possesses extensive experience in GxP system architecture and integration, strong leadership skills, and a deep understanding of GxP requirements. This role offers a competitive compensation and benefits package, including a base salary, performance bonus, equity grant opportunities, and flexible PTO. Apogee fosters a collaborative and innovative work environment.

Requirements

• 8+ years of experience in systems architecture, integration, or similar roles in a biotech or pharmaceutical environment
• Expertise in GxP system integration, including hands-on experience with middleware integration tools (e.g., Mulesoft)
• Experience with clinical, quality, and regulatory systems (e.g., eTMF, QMS, Regulatory Submissions) in a GxP environment
• Strong understanding of GxP requirements, data integrity, and compliance
• Proven ability to manage multiple complex projects and work effectively with both technical and non-technical stakeholders
• Strong leadership skills with a growth mindset, dedicated to fostering a psychologically safe and innovative work environment
• Successfully exhibit Apogee’s C.O.R.E. values: C aring, O riginal, R esilient and E goless
• Ability to travel appropriately 10 – 15%

Responsibilities

• Administer and maintain GxP systems to ensure reliability, compliance, and data integrity
• Monitor system performance and take proactive steps to address potential issues
• Troubleshoot system issues and work with vendors for timely resolution
• Ensure that system configurations are aligned with business and compliance requirements
• Design and implement solutions to support Quality, Regulatory, Clinical, Medical Affairs, and Biometrics teams
• Architect and maintain the integration of R&D and GxP systems, identifying and addressing gaps in the current system landscape
• Provide technical guidance and expertise throughout the lifecycle of system implementations and enhancements
• Lead integration efforts across GxP systems using tools like middleware integration platforms
• Ensure data flows seamlessly between systems, leveraging the latest features and updates
• Collaborate with external vendors and implementation partners to optimize system functionality
• Evaluate and implement integration solutions that enhance scalability and efficiency as the company expands
• Ensure data integrity, security, and compliance for all R&D systems
• Implement best practices for data governance and ensure that all systems meet GxP compliance requirements
• Provide regular training and support to system users to maintain compliance and efficient use of the systems
• Develop and maintain documentation to support regulatory audits and inspections
• Foster a collaborative and high-performing IT team, providing mentorship, guidance, and opportunities for professional growth
• Instill a culture of continuous improvement and innovation within the IT department
• Lead efforts to provide regular training and support to system users, ensuring efficient use of GxP systems
• Build strong cross-functional relationships to ensure IT alignment with business needs during scaling initiatives

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve