Manager, Quality and Compliance
Core
Ensuring compliance with FDA and regulatory agency requirements, managing internal and client audits, and overseeing supplier quality management for biologics manufacturing.
Role type
Manager, Quality and Compliance
Builds
Regulatory compliant biologics manufacturing processes and drug products
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
client delivery
Required skills
Regulatory compliance management, audit leadership, supplier quality management, process validation, team performance management, stakeholder liaison
Preferred skills
Advanced theoretical knowledge in quality systems, industry compliance trend analysis
Technologies
PPQ, CPV, APR
Responsibilities
Manage Quality Assurance resources for audits and regulatory support; Establish training expectations for QA personnel; Serve as regulatory liaison for Health Authorities; Lead team members to improve performance; Monitor industry compliance trends
Seniority
Manager, hands-on leadership
