Global Quality Manager - MCOQ US Quality Manager · MCOQ- US Region

Fri, 24 Apr 2026 14:19:03 GMT
Quality Assurance

MCOQ- US Region · Wilmington, Delaware, United States of America · onsite

This role will ensure excellence in Marketing Company GMP & GDP Quality activities to maintain the local License to Operate (LTO), driving compliance, quality performance, and continuous improvement across the US market and aligned cluster.

Key Responsibilities: Governance and Leadership Serve as back-up to the Cluster Lead as the GMP/GDP contact for the region. Maintain an effective governance structure that provides transparent oversight of quality activities and risk management. Act as a core member of the Marketing Company Quality Regional Leadership Team, contributing to strategy, prioritization, and resource planning. Lead, manage, and develop team members in a multi-layered organization; set objectives and build capabilities to deliver against global processes and local needs.

Strategy, Policy, and Quality System Execution Collaborate with the US Cluster to define and deploy the GMP & GDP strategy across markets and the commercial SET area, partnering with Commercial SET leaders, Regional Commercial Heads, and Global Patient Safety. Shape and execute the Marketing Company GMP/GDP Quality System and framework, including change control, quality events, CAPA oversight, deviation/incident management, and documentation practices. Define, implement, and monitor GMP/GDP policies and standards in market; drive global standardization, simplification, and continuous improvement of Marketing Company Quality processes.

Management Review, Performance, and Reporting Support the Marketing Company Quality Management Review (QMR) process, including preparation, execution, and escalation to Operations, Commercial, and R&D senior leadership and SET members. Contribute to compliance and performance reporting to AstraZeneca Operations Leadership for Marketing Company Quality metrics and insights. Support budget planning and management for the Marketing Company Quality organization.

Regulatory Compliance and Inspection Readiness Maintain current knowledge of country-specific regulatory requirements for manufacturing and distribution; ensure audit/inspection readiness and compliance to sustain AZ’s LTO. Lead/oversee resolution of Issue Management, FARs, BPDRs, recalls, and regulatory interactions as appropriate, ensuring timely and compliant outcomes.

US Product Quality Complaints (PQC) Leadership Act as Regional Process Champion for the PQC process. Oversee end-to-end US PQC intake, triage, and communication to supply sites, ensuring consistent, clear, and timely reporting aligned with AZ policies. Integrate across stakeholders (MCOQ Regional Process Network, US Operations, US Patient Safety, global supply sites) to ensure awareness of new programs and drive customer feedback into supply and functional teams. Partner with the AZ Information Center (AZIC) to maintain an accurate, comprehensive knowledge base aligned to US PQC policies. Collaborate with the Vendor Management Team to monitor IQVIA performance (e.g., weekly quality checks), identify opportunities, and drive improvements.

People and Capability Provide training, support, and coaching on GMP/GDP requirements and practices to Marketing Company personnel. Contribute to integration activities for divestments, acquisitions, and licensing agreements by providing Marketing Company GMP/GDP quality input for the region.