Associate Director, IT GxP & Quality Systems

Role: Associate Director of IT GxP & Quality Systems, responsible for leading strategic GxP technology programs and managing the Quality Management Systems environment to ensure compliance and operational excellence within a regulated biopharma setting. Responsibilities include overseeing the lifecycle, governance, and optimization of GxP platforms, driving process automation and continuous improvement initiatives, and supporting cross-functional programs across Quality, Clinical, Manufacturing, and Regulatory functions. The role entails managing vendor relationships, ensuring compliance with regulations such as FDA 21 CFR Part 11 and EU Annex 11, leading validation activities, and maintaining inspection readiness. It also involves leading cross-functional teams, influencing decision-making, and aligning technology initiatives with organizational strategies. Qualifications include a bachelor’s degree in Life Sciences, IT, Engineering, or related fields, with 10+ years of experience in regulated industries, particularly with GxP systems like MasterControl, Veeva, or LabVantage. Experience with quality processes, validation, data integrity, and regulated business support (e.g., clinical, manufacturing, cell/gene therapies) is essential. The role requires strong stakeholder management, program leadership, and communication skills, with a focus on strategic impact and transformation. The position supports enterprise-wide deployment, continuous improvement of Quality Systems, and manages external vendors and partners, with an emphasis on compliance, quality, and scalable technology solutions.