Digital & Data Quality Director - US
Core
Lead the Digital and Data Quality organization to ensure compliance and quality of GMP computerized systems, automated manufacturing equipment, and data analysis tools within the pharmaceutical manufacturing division.
Role type
Director of Quality Systems and Data Integrity
Builds
Validated enterprise systems and GMP-compliant data controls for manufacturing and laboratory processes
Domain
Regulated pharmaceutical manufacturing and computerized system validation
Required skills
Computerized System Validation (CSV), Data Integrity, GMP Compliance, FDA Regulations, 21 CFR Part 11, GAMP, Risk Management, Quality Auditing, Change Management, Regulatory Inspections
Preferred skills
Lean Six Sigma, PMP, Cross-functional Leadership, Strategic Planning, Root Cause Analysis
Technologies
GMP computerized systems, Automated manufacturing equipment, Automated laboratory systems, Data analysis tools
Responsibilities
Support regulatory inspections and audits, Manage DDQ resources and team development, Ensure compliance with company policies and regulatory expectations, Align team goals with quality objectives, Model leadership behaviors and values
Seniority
Director, strategic leadership with hands-on oversight