Global Quality Manager - MCOQ US Quality Manager
Astrazeneca, Wilmington, DE, United States
- Relevant skills and experience will be listed so you know why those jobs are a match## Job DescriptionThis 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.**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.
+ 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.* 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.**Essential Qualifications*** 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.**Desirable Qualifications*** Line management experience* Post-graduate degreeBring your expertise to a role that safeguards our **License to Operate**, elevates **GMP/GDP excellence**, and accelerates **continuous improvement**
***Apply today!*****Date Posted**21-Apr-2026**Closing Date**04-May-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.## Get MatchedUpload your resume and see jobs that match your skills and experience### Popular Skills of Previous Hires* Business Operations* Budgeting* Operations* ManagementPatient Education Manager, Hematology and Nephrology, Southeast (GA, FL, and Puerto Rico)Wilmington, Delaware, United States of AmericaSAMM - Managed Markets Sales## Career benefits### Aligned to performanceOur approach is designed to stimulate our commercial growth, scientific advancement, collaboration and personal development.### BalancedOur benefits offering is flexible where possible, empowering you to choose the benefits that work for you.### HolisticWe aim to reward everything you do here and value you for the contributions and unique insights you'll bring.### SustainableWe build reward practices to be sustainable and affordable for the business, now and into the future.# Our PhilosophyAstraZeneca is a global, science-led, patient-focused pharmaceutical company committed to excellence in the research, development and commercialisation of prescription medicines. With approximately 90,000 people in 85 countries, our aim is simple: to unlock the power of what science can do, for people, society and the planet. From Clinical Development, Regulatory and Medical Affairs to Finance, IT, Digital, Manufacturing and Supply, the opportunities to make an impact are limitless. Our workforce reflects the diversity of the patients we serve – it is embedded in everything we do. We're at our best and most creative when we seek out different perspectives, experiences and strengths. At AstraZeneca, you'll
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+ 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.
+ 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.* 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.**Essential Qualifications*** 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.**Desirable Qualifications*** Line management experience* Post-graduate degreeBring your expertise to a role that safeguards our **License to Operate**, elevates **GMP/GDP excellence**, and accelerates **continuous improvement**
***Apply today!*****Date Posted**21-Apr-2026**Closing Date**04-May-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.## Get MatchedUpload your resume and see jobs that match your skills and experience### Popular Skills of Previous Hires* Business Operations* Budgeting* Operations* ManagementPatient Education Manager, Hematology and Nephrology, Southeast (GA, FL, and Puerto Rico)Wilmington, Delaware, United States of AmericaSAMM - Managed Markets Sales## Career benefits### Aligned to performanceOur approach is designed to stimulate our commercial growth, scientific advancement, collaboration and personal development.### BalancedOur benefits offering is flexible where possible, empowering you to choose the benefits that work for you.### HolisticWe aim to reward everything you do here and value you for the contributions and unique insights you'll bring.### SustainableWe build reward practices to be sustainable and affordable for the business, now and into the future.# Our PhilosophyAstraZeneca is a global, science-led, patient-focused pharmaceutical company committed to excellence in the research, development and commercialisation of prescription medicines. With approximately 90,000 people in 85 countries, our aim is simple: to unlock the power of what science can do, for people, society and the planet. From Clinical Development, Regulatory and Medical Affairs to Finance, IT, Digital, Manufacturing and Supply, the opportunities to make an impact are limitless. Our workforce reflects the diversity of the patients we serve – it is embedded in everything we do. We're at our best and most creative when we seek out different perspectives, experiences and strengths. At AstraZeneca, you'll
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