Quality Director – Marketing Company OQ Regional Lead,

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe. Our Gaithersburg, Maryland facility builds life-changing medicines for people around the world. The modern, vibrant scientific campus employs more than 3000 guides in our field, and it is only a short drive from Washington, DC. It is filled with groundbreaking technology. Our labs spaces were built to facilitate collaboration, interaction and cross functional science. We believe employees benefit from being challenged and encouraged at work. We offer everything from bean bag rooms for creative brain storming, game rooms and Zen garden to treadmill stations and regular campus happy hours. The Gaithersburg site offer a variety of amenities to help boost efficiency and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center.

 Join AstraZeneca and help us deliver life-changing medicines! Be among our employees who continue to make us an innovation-driven company that stands firmly among the leaders in BioPharmaceuticals

Brief Description:

This person will be the responsible party for overseeing the design, implementation and delivery of a common Quality system and strategy for GMP and GDP activities across  Commercial marketing companies for all of the AZ product portfolio in region.  Participates in development of Global AZ Marketing Company Quality Strategy and executes regional strategy for Marketing Company Quality and Marketing Company GMP/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 activities and connects the Marketing Company offices the broader Operations Quality and R&D organization operating under One AZ QMS.  

What you’ll do:

• Provides leadership for GMP & GDP (Good Manufacturing and Good Distribution Practice) strategy and activities across all markets and commercial SET areas in Region as the Quality partner to Commercial SET leaders, Regional Commercial Heads and Global Safety
• Participates in defining the strategy for the commercial global markets ownership and execution of Marketing Company GMP and GDP Quality System and framework in Region
• Define, develop, deploy and monitor the GMP/GDP policies and standards and execution in Regional markets
• Accountable for a Regional Marketing Company Quality Management Review process, preparation and execution and escalations to Operations, Commercial and R&D Sr. Leadership and SET members
• Contributes or leads preparation of Compliance reporting to AstraZeneca Operations Leadership and routine Board of Directors Compliance committee related to Marketing Company Quality performance
• Represents Quality on cross-functional and cross SET teams and steering committees related to Marketing Company markets
• Drive global standardization, simplification and improvement of Marketing Company Quality business processes.  Develops and sustains a high-quality organization 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 regional Quality Marketing Company network roles
• Participates in strategy and regional objectives setting for the Marketing Company Quality organization and leads, manages and develops team members in a multi-layered organization
• Is the primary point of expertise for GMP & GDP  activities impacting the Marketing Company organization in Region
• Plans, reviews and manages budgets for the Regional Marketing Company Quality organization
• Accountable for compliance assurance and working to one set of GMP & GDP standards and processes, as well as common GxP process across the Marketing Company GxPs.
• Accountable for Regional and Country specific regulatory requirements related to manufacture and distribution of AZ product in country, including but not limited to release of product batched, resolution of Issue Management, recalls, influence and decisions on local regulatory agency interactions, audits and inspection readiness and compliance to gain and maintain AZ license to operate.
• Responsible for Marketing Company GMP&GDP input into divestments/acquisitions/licensing agreements in region
• Member of the Marketing Company Quality Leadership Team

Essential for the role:

• Demonstrated expert level knowledge of GMP/GDP quality management. Demonstrated ability to deliver a GMP/GDP quality strategy across multiple countries Collaborative/matrix management skills (7+ years of experience)
• Experience in GMP/GDP country roles
• Ability to deliver near and longer term Marketing Company GMP/GDP strategy across regions and countries 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
• Ensures local teams have the skills and capabilities to meet company and regulatory standards for their GMP/GDP activities.
• Reviews GMP/GDP specific quality management data such as risk and issues data for trends and compliance with QMS standards
• Ensures effective and timely complaint management by MCs
• Develops the GMP/GDP training and capability plan for MCs to ensure local GMP/GDP

Desirable

• Operational expertise in Quality management
• Excellent knowledge of AstraZeneca policies, procedures and guidelines

• Excellent understanding of AstraZeneca, its people strategy, business, products and Patient Safety pipeline
• Experience in GMP/GDP above country roles

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being bold - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking innovative methods and bringing unexpected teams together. Interested? Come and join our journey.

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Next Steps – Apply today!

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 requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.