Director, Data Management Process, Quality & Inspection Readiness
$183.1k - $305.2kRegeneron Pharmaceuticals, Inc.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 27 days ago
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