Director, Applications, Regulated & Commercial Systems

Role: Application Manager supporting regulated functions within a biopharma context, focusing on GxP-compliant business applications used by Clinical Operations, Regulatory Affairs, Quality, and Pharmacovigilance. Responsibilities include managing application lifecycle activities, vendor coordination, system validation, change control, audit readiness, and ensuring compliance with GxP, 21 CFR Part 11, and Annex 11. The role involves collaborating with cross-functional teams across the US and Europe, supporting future CRM platform implementation, and participating in related validation and deployment efforts. Qualifications: Bachelor's in IT, Computer Science, or related field; significant experience managing SaaS applications in biotech/pharma settings; deep understanding of GxP and validation standards; familiarity with Clinical, Regulatory, Quality, or PV applications, and CRM systems is highly advantageous. Preferred: advanced degrees (MBA, PharmD, PhD), experience in remote US East Coast environment, and occasional travel to France. The position offers an opportunity to influence the evolution of regulated and commercial applications supporting late-stage development and commercialization within a global biotech firm. Location: US East Coast, remote with occasional travel.