Provide oversight and ensure full compliance of quality, customer, and regulatory requirements for Quality Systems, Audits/Inspections, QA Validation, and Data Integrity
Job Summary
Provide oversight and ensure full compliance of quality, customer, and regulatory requirements for Quality Systems, Audits/Inspections, QA Validation, and Data Integrity.
Drive best-in-industry continuous improvement by growing quality, compliance and efficiency standards, with comprehensive quality oversight for customers with high value products.
Develop technical, supervisory and managerial staff to improve personal and site performance and build developmental plans for high potential staff.
Matching Summary
Provide oversight and ensure full compliance of quality, customer, and regulatory requirements for Quality Systems, Audits/Inspections, QA Validation, and Data Integrity.
Skills & Requirements
Must-have
Quality Systems oversight
Audit and Inspection management
Data Integrity assurance
cGMP compliance standards
Customer quality requirements
Nice-to-have
Employee engagement and development
Influencing at distance
Driving organization change
Embracing diversity
Continuous improvement initiatives
Key Requirements
Bachelor’s degree in Physical Sciences, Engineering or related field
10+ years of cGMP experience
5 years of Quality Systems & Compliance experience
8 years in a leadership role
Advanced cGMP experience
In depth knowledge of pharmaceutical contract manufacturing, QA, Compliance, QC and RA