Global Quality Manager - MCOQ US Quality Manager

AstraZeneca • Wilmington, DE

1d

About The Position

This position 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company focused on discovering, developing, and commercializing prescription medicines for serious diseases. The company is dedicated to being a Great Place to Work, empowering employees to push the boundaries of science, challenge convention, and unleash their entrepreneurial spirit. AstraZeneca embraces differences and takes bold actions to drive change to meet global healthcare and sustainability challenges. It fosters an inclusive culture where diverse thinking generates new opportunities, with a commitment to lifelong learning, growth, and development for all. The Inclusion & Diversity mission is to create an inclusive and equitable environment where people belong, leveraging diversity to drive innovation and deliver life-changing medicines to patients. The company values curiosity about science, creative problem-solving, and accountability, aiming to help colleagues realize their full potential and make a significant impact on medicine, patients, and society.

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.

Benefits

• An inclusive environment where equal employment opportunities are available to all applicants and employees.
• Accommodation for disability or special need.
• A Great Place to Work where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit.
• Embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.
• An inclusive culture where you will connect different thinking to generate new and valuable opportunities.
• A commitment to lifelong learning, growth and development for all.
• An inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients.
• Opportunity to do work that has the potential to change your life and improve countless others.
• Shape a culture that unites and inspires us every day.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees