Associate Director, Global Quality Compliance Lead

Role Overview

• Support global pharmaceutical manufacturing operations and ensure compliance with cGMP, regulatory, and quality standards across internal and external supply sites
• Lead and support global quality compliance projects focused on patient supply, quality systems improvement, deviation reduction, human error reduction, Veeva implementation, quality compliance de-risking, modernization initiatives, and safety labeling oversight in partnership with PV and Regulatory
• Support inspection readiness and Health Authority inspections, including SME preparation, coaching, remediation activities, inspection response support, and CAPA effectiveness monitoring
• Provide sterility assurance and contamination control expertise, including oversight of contamination control strategies (CCS), environmental monitoring, sterility testing, microbial enumeration/bioburden, endotoxin testing, and Low Endotoxin Recovery (LER) risk mitigation
• Oversee product quality incident management and support complex investigations utilizing robust root cause analysis and CAPA processes
• Lead and support multi-site/global quality compliance investigations and initiatives across manufacturing operations
• Provide guidance on global quality standards, cGMP requirements, regulatory expectations, and quality risk management practices across supply operations
• Review and assess inspection readiness dashboards, self-audit programs, compliance trends, and CAPA effectiveness for critical supply sites
• 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
• Execute oversight activities related to global safety labeling program monitoring and implementation effectiveness
• Partner cross-functionally on EMA inspection readiness activities and Pharmacovigilance (PV) Health Authority inspections as a Quality SME
• 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 managing or supporting cross-site/global quality compliance initiatives across multiple manufacturing locations
• Experience writing/reviewing CAPAs, deviations, root cause investigations, and remediation plans
• Experience working within pharmaceutical manufacturing environments involving sterile products, non-sterile products, biologics, biosimilars, or medical devices
• Comfortable working in a highly matrixed global environment with cross-functional stakeholders

Benefits

• Generous annual leave
• Flexible working schedules (dependent on role)
• Access to tailored health support
• Meaningful ways to give back to the community