Director, Data Management Process, Quality & Inspection Readiness
Regeneron · Warren +2 more
BiometricsFull-time$183k–$305kCompany career page
The apply link worked recently (not employer-confirmed).
What they're looking for
- Bachelor's degree in science, health, computing, or related field
- 12+ years clinical data management experience in biotech or pharma
- 5+ years people management and leadership experience
- Expert knowledge of clinical data management principles and processes
- Understanding of GCP, ICH guidelines, and global regulatory requirements
- Experience with quality event management and CAPA activities
- Health authority inspection and audit preparation experience
What you'll be doing
- Establish and drive Data Management quality frameworks, compliance standards, and governance aligned with regulatory requirements
- Lead inspection readiness activities and coordinate responses for health authority inspections and audits
- Develop, govern, and improve Data Management processes, training programs, and operational frameworks
- Manage quality events, CAPA activities, and root cause analysis to strengthen controls and compliance
- Line manage direct reports with focus on competency development, coaching, and performance assessment
Privacy & handoff
This role links to Regeneron's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.