Associate Director, Global Quality Compliance Lead
Haarlem, North Holland, Netherlands, Kingdom of the
Full Time
2 hours ago
Visa Sponsorship
Key skills
Risk Management
About this role
Role Overview
Support global pharmaceutical manufacturing operations and ensure compliance with cGMP, regulatory, and quality standards
Lead and support global quality compliance projects focused on patient supply, quality systems improvement, deviation reduction, human error reduction
Provide sterility assurance and contamination control expertise, including oversight of contamination control strategies, environmental monitoring, sterility testing, microbial enumeration/bioburden, endotoxin testing
Oversee product quality incident management and support complex investigations utilizing robust root cause analysis and CAPA processes
Develop, review, and monitor Quality Improvement Plans (QIPs) and KPI performance measures to minimize compliance risk and improve quality performance
Support and contribute to Teva’s Global Compliance Network through GxP interpretation, lessons learned, regulatory intelligence, and quality knowledge management
Represent Teva in industry working groups and contribute to regulatory policy and guidance discussions
Requirements
Bachelor’s degree required, preferably in related field or higher education preferred.
A minimum of 8-12 years of pharmaceutical quality/compliance experience in GMP-regulated manufacturing environments or quality control microbiology
Strong experience in sterile manufacturing, biologics, medical devices, or biosimilars
Advanced knowledge of cGMPs, quality systems, audits, inspections, CAPA, and risk management
Direct experience supporting sterile/aseptic manufacturing operations and contamination control programs
Experience supporting Health Authority inspections (FDA, EMA, MHRA, etc.), including inspection readiness and response management
Hands-on experience with microbiology quality systems, including sterility testing, bioburden, endotoxin testing, and contamination investigations
Experience writing/reviewing CAPAs, deviations, root cause investigations, and remediation plans
Comfortable working in a highly matrixed global environment with cross-functional stakeholders