Director, Data Quality & Inspection Readiness

Regeneron Pharmaceuticals, Inc.; New Jersey; Hybrid; USD 183,100 - 305,200; Full time

Benefits offered by this job

Annual bonuses

Equity awards

401(k) company match

Health and wellness programs

Paid time off

Job summary

Regeneron is seeking a Director of Data Management Quality and Inspection Readiness to provide strategic leadership for data management quality, inspection readiness, and process excellence. You will establish frameworks aligned with GCP, ICH guidelines, and global regulatory requirements, serving as the primary lead for health authority inspections and audits.

The role requires 12+ years in Clinical Data Management with 5+ years of people leadership, along with expert knowledge of quality

Qualifications

• Bachelor's degree in science, health, computing, or related field with 12+ years in Clinical Data Management.
• Experience leading data management quality, compliance, and inspection readiness in a global environment.
• Proven ability to develop and implement quality standards, CAPA, and governance across functions.

Responsibilities

• Provide strategic leadership for Data Management quality and compliance.
• Lead inspection readiness and health authority inspection support.
• Develop quality frameworks, governance, issue management, and CAPA processes.
• Collaborate with CROs and internal stakeholders on quality events and remediation.
• Establish KPI/KQI frameworks and drive continuous improvement.
• Oversee Data Management training, processes, and documentation.
• Lead cross‑functional process improvement initiatives.
• Manage people and mentor direct reports to high performance.
• Represent Data Management in regulatory inspections and audits.

Skills

Data Management quality

Inspection readiness

Quality governance

CAPA management

Regulatory compliance

GCP/ICH knowledge

KPI & KPI frameworks

Cross-functional leadership

Change management

Regulatory inspections experience

Education

Bachelor's degree in Science/Health/Computing

Job description

Regeneron is seeking a Director of Data Management Quality and Inspection Readiness to provide strategic leadership for data management quality, inspection readiness, and process excellence. You will establish frameworks aligned with GCP, ICH guidelines, and global regulatory requirements, serving as the primary lead for health authority inspections and audits.

The role requires 12+ years in Clinical Data Management with 5+ years of people leadership, along with expert knowledge of quality