Director Marketing Company Operations Quality

JOB TITLE

Director Marketing Company Operations Quality (MEA Cluster)

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

ROLE SUMMARY

• Overall responsible for overseeing the design, implementation and delivery of a common Quality system and
• strategy for GMP and GDP activities across Middle East Africa (MEA) Cluster of Commercial Marketing
• Companies for all the AstraZeneca (AZ) product portfolio in cluster.
• Participates in development of International AZ Marketing Company Operations Quality (MCOQ) Strategy and
• executes cluster strategy for MCOQ and Marketing Company (MC) Good Manufacturing Practice (GMP) &
• Good Distribution Practice (GDP) aligned with AZ’s 2030 bold ambition strategy for market expansion, product
• launches and accessibility.
• Accountable for assurance of compliance with worldwide standards for all local GMP & GDP.
• Lead a team of quality leaders and professionals in the MCOQ MEA cluster.

What you’ll do

Overview

Develop, support and drive excellence in MCOQ activities to maintain the local License to Operate (LTO) within the Cluster.  Primary point of expertise for GMP & GDP contact for the cluster, contributes and supports the development of the applicable processes and procedures and maintains an effective governance structure to ensure oversight of quality activities.

Quality Management System (QMS) Scope

Provides leadership for GMP & GDP strategy and activities across the cluster as the Quality partner to Commercial SET leaders, Heads and Global Safety. Accountable for MEA Quality Management Review process, preparation, execution and escalations to Operations, Commercial and R&D Senior Leadership and SET members, including reporting of quality metrics as appropriate. Participates in defining the strategy for the commercial international markets ownership and execution of MCOQ GMP and GDP Quality System and framework in cluster. Deploy and monitor the GMP & GDP policies and standards as well as the execution in cluster markets. Represents Quality on cross-functional, cross SET teams and steering committees related to markets.  Drive cluster standardisation, simplification, and improvement of MCOQ business processes. Develops and sustains a high-quality organisation that delivers against global processes, and aims to continuously improve in competence, compliance standards and innovative delivery of results. Provide training, supporting and coaching structure for cluster Quality Affiliate network roles. Participates in strategy and cluster objectives setting for the Affiliate Quality organisation and leads, manages and develops team members in a multi-layered organization. Partners with cross functional teams to manage QMS processes within the cluster, which includes but not limited to the following:

• Audits and Inspection process.
• Complaint management process; including temperature excursions & supply and logistics events.
• Deviation/CAPA/Change control management process.
• Document management process.
• Plans, reviews and manages budgets for the cluster MCOQ organisation.
• Third Party management process.
• Issue Management, including Recalls, Product Returns, Rejections & Destruction.
• Quality Risk Management
• GMP & GDP Training Management process.
• Evaluation and coordination of any in cluster pack conversion, repacking and over-labelling activities with the goal to ensure supply and distribution of quality products to the respective markets

Accountable for compliance assurance and working to one set of GMP & GDP standards and processes, as well as common GxP process across the Affiliate GDP’s. Accountable for cluster and country specific regulatory requirements related to manufacture and distribution of AZ product in country, including but not limited to product release, resolution of Issue Management, recalls, influence and decisions on local regulatory agency interactions, audits and inspection readiness and compliance to gain and maintain AZ licence to operate. Responsible for MCOQ GMP & GDP input into divestments/ acquisitions/ licensing agreements in cluster.  Fulfil the role of GMP & GDP Quality Lead which covers but not limited to the following:

• Ensuring the GMP & GDP area is run in accordance with quality requirements stipulated in the external regulations and internal AZ quality standard and processes.
• Ensuring appropriate levels of resource to complete GMP & GDP activities. o Providing and coordinating training and coaching in the GMP & GDP area for the MC QMS.
• Identifying and agreeing areas of compliance risk and follow-up of any issues.
• Ensuring GxP self-assessments in GMP & GDP o Monitoring KPIs in the GMP & GDP area and proposing remedial and improvement actions.
• Establishing improvement priorities.
• Monitoring internal/external factors such as emerging regulation or shifts in regulatory enforcement.
• Identifying trends and communicating identified risks.
• Establishing and maintaining business continuity plans in the GMP & GDP area.

Essential for the role

• Degree or equivalent professional qualification in related field
• Experience in quality assurance within a pharmaceutical company and/or distribution environment
• Demonstrated expert level knowledge of GMP & GDP quality management; Experience in GMP & GDP country roles.
• 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 AZ’s LTO for GMP & GD.

Desirable for the role

• Operational expertise in Quality management
• Good understanding of AZ, its people strategy, business, products and Patient Safety pipeline
• Prior experience as a Responsible Person in the pharmaceutical industry, been fully trained and qualified for the RP role.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

Follow AstraZeneca on Facebook

Follow AstraZeneca on Instagram

Date Posted

11-أغسطس-2025

Closing Date

20-أغسطس-2025

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.