Sr Manager, Quality Assurance
Core
Lead the Quality Systems function to ensure compliance with cGMP and regulatory requirements in a pharmaceutical manufacturing environment.
Role type
Senior Manager, Quality Assurance
Builds
Quality Management System, compliance framework, and audit readiness
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
cGMP knowledge, Quality Management Systems expertise, regulatory compliance, data integrity, risk-based decision-making, people leadership, cross-functional collaboration
Preferred skills
Advanced scientific or business degree, experience with electronic Quality Systems
Technologies
Electronic document management systems, learning management systems, electronic Quality Systems software
Responsibilities
Provide leadership and oversight for Quality Systems activities; Establish oversight of Quality System performance through metrics and trending; Maintain knowledge of manufacturing standards and global regulatory requirements; Lead Product Complaint and APQR Quality Systems; Ensure alignment of systems with data integrity principles; Promote inspection and audit readiness; Champion continuous improvement across Quality Systems; Lead, coach, and develop Quality Systems personnel
Seniority
Senior Manager, hands-on leadership
