Teva is seeking an Associate Director, Global Quality Compliance Lead to support global pharmaceutical manufacturing operations and ensure compliance with cGMP, regulatory, and quality standards across internal and external supply sites. This role will 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.
Responsibilities
* 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
* 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
Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.
Education, Certification, and Experience
* 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.
Skills, Knowledge, and Abilities
* Strong experience in sterile manufacturing, biologics, medical devices, or biosimilars
* Advanced knowledge of cGMPs, quality systems, audits, inspections, CAPA, and risk management
* Strong communication, leadership, and project management skills
* 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
Travel Requirements
* Up to 30% domestic and international travel involved
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