Director – IT Development Business Partner and Gxp Compliance Lead

Director – IT Development Business Partner and Gxp Compliance Lead

Requirements

• Bachelor’s degree in information technology, computer science, or relevant field.
• At least 9 years of relevant experience in development business partner or related roles, preferably in a GxP regulated biotech or pharmaceutical environment.
• Strong understanding of regulatory frameworks relevant to a clinical stage biotech organization.

Responsibilities

• Serve as the primary IT liaison for Quality, Regulatory, Clinical, and other development teams, building strong relationships with stakeholders to understand their strategic goals, operational needs, and opportunities for improvement.
• Lead IT GxP compliance initiatives as a subject matter expert, driving accountability across teams.
• Oversee the creation of SOPs, documentation, and training programs that meet GxP standards (e.g., 21 CFR Part 11).
• Ensure audit and inspection readiness by maintaining accurate systems documentation, upholding data integrity, and partnering with auditors to implement, communicate, and remediate processes effectively.
• Drive the planning, execution, and validation of key projects by aligning priorities, requirements, and timelines with company goals.
• Allocate resources strategically to maximize efficiency, make confident decisions to keep projects on track, and provide recommendations to shape timelines, goals, and resource allocation for success.
• Oversee the selection, implementation, and validation of development systems, ensuring compliance with relevant standards.
• Provide ongoing technical support, troubleshoot issues, and serve as a resource for technical and process-related inquiries.
• Set clear objectives, delegate responsibilities, and inspire your team to execute plans with focus and alignment to company priorities.
• Mentor team members, fostering collaboration, resolving roadblocks, and maintaining peak performance.
• Cultivate an inclusive and collaborative culture that empowers the team to achieve shared goals and models company values.
• Build strong connections with senior management, colleagues, and external stakeholders, influencing key outcomes and providing insights that shape critical decisions and drive organizational success in high-impact situations.
• Other duties as assigned.

Preferred Qualifications

No preferred qualifications provided.