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 initiatives, inspection readiness activities, complex investigations, and continuous improvement programs with a strong focus on sterility assurance, contamination control, microbiology oversight, and patient safety
• provide targeted support based on critical business needs and quality/compliance risks
• 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
• execute oversight activities related to global safety labeling program monitoring and implementation effectiveness

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

Benefits

• generous annual leave
• reward plans
• access to tailored health support
• meaningful ways to give back to the community
• career development platform