Global Quality Manager - MCOQ US Quality Manager

AstraZeneca•Wilmington, DE

About The Position

This position is responsible for ensuring 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. The role involves establishing and maintaining an effective governance structure, contributing to strategic planning, and leading and developing team members. It also encompasses defining and deploying GMP & GDP strategy, executing the Marketing Company GMP/GDP Quality System, and monitoring policies and standards. Furthermore, the manager will support Quality Management Reviews, contribute to compliance reporting, and manage budget planning. A key aspect is maintaining regulatory compliance, ensuring inspection readiness, and leading the resolution of quality issues and regulatory interactions. The role also includes leadership for US Product Quality Complaints (PQC), overseeing the end-to-end process, integrating with stakeholders, partnering with the AZ Information Center, and monitoring vendor performance. Finally, the position involves providing training and coaching on GMP/GDP requirements and contributing to integration activities for divestments, acquisitions, and licensing agreements.

Requirements

Qualified to degree level (Bachelor's) preferably in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering
Minimum of 7 years in Operations or Quality Assurance within either the pharmaceutical industry, Biopharma or medical device industries
Demonstrated strong level knowledge of GMP/GDP quality management processes.
Key focus area on Complaint Management skills.
Ability to support delivery near and longer term of Marketing Company GMP/GDP strategy across market in AZ Commercial network and partners.
Excellent communication and organization skills with ability to make decisions and influence outcomes related to patient supply and AZ reputation.
Strong business acumen with Integrity and high ethical standards.
Ensures AstraZeneca’s license to operate for GMP/GDP through development and delivery of effective strategies for GMP/GDP in local marketing companies.
A broad understanding of the technical requirements within Quality and an ability to balance this with industry standards to achieve business goals
Ability to develop training materials and support coaching and training for team.
Proven leadership skills
Demonstrated ability to work independently and effectively in a cross-functional team environment with ability to work across cultures.
Demonstrated ability to manage multiple competing assignments and timelines.
Excellent communication skills, both oral and written.
Demonstrated ability to influence whilst maintaining independent and objective views.
Demonstrates ability to maintain high ethical standards, including a commitment to organization values and behaviors.

Nice To Haves

Line management experience
Post-graduate degree

Responsibilities

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.
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.
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.
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.
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.
Support projects, pilots, and initiatives aligned to supply site, US Operations, and US Commercial goals.
Support and participate in internal audits and external regulatory inspections of the US PQC process.
Provide oversight for Drug Quality MedWatch reports from FDA in accordance with local requirements.
Stay current with evolving US regulatory requirements and best practices related to PQCs.
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.