Quality Specialist MCOQ

Quality Specialist MCOQ

Join AstraZeneca: Where Science and Innovation Meet

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to discovering, developing, and commercializing prescription medicines for some of the world’s most serious diseases. We are seeking a passionate Quality Specialist MCOQ to contribute to our mission and help shape the future of healthcare.

About the Role:

As a Quality Specialist MCOQ, you will be pivotal in designing and executing a comprehensive Quality Management System (QMS) and strategy for GMP and GDP activities across the Commercial Marketing Company (MC) for AstraZeneca's product portfolio in your country. Reporting to the CEEBA cluster lead, you will be an integral part of our Global Quality Organization.

Main Tasks and Responsibilities:

• Leadership and Strategy: Provide leadership for GMP & GDP strategies, serving as the quality partner to commercial leaders.
• Quality System Execution: Participate in defining and executing the MCOQ GMP and GDP Quality System and framework in-country.
• Policy Development: Define, develop, deploy, and monitor GMP/GDP policies and standards. Ensure documentation meets local regulatory standards and maintain lifecycle management.
• Management Review: Oversee the Country MC Quality Management Review process, including preparation, execution, and escalations to senior leadership.
• Cross-Functional Representation: Represent Quality on cross-functional teams and steering committees related to the MC market.
• Standardization and Improvement: Support global standardization, simplification, and improvement of MCOQ Quality business processes.
• Budget Management: Plan, review, and manage the budget for the Country MCOQ Quality organization.
• Local MCOQ Activities: Manage activities related to issue management, product quality, regulatory interactions, and more.
• Change and Vendor Management: Ensure change management and vendor management processes are followed.
• Risk Management: Follow the quality risk management process and maintain an active risk register.
• Regulatory Preparation: Prepare for MCOQ-related Regulatory Agency and AstraZeneca inspections/audits and responses.
• Self-Assessment and Compliance: Implement an effective MCOQ self-assessment program, ensuring QMS compliance and continuous improvement.
• Quality Culture Promotion: Promote a Quality Culture in the MC and ensure GDP/GMP/QMS training is performed.
• Regional Support: Provide support to other MCs in the CEEBA region.
• Safety and Environment Compliance: Ensure compliance with Safety, Health, and Environment regulations.

Your Profile:

• A university degree in pharmacy, life sciences, or a related field.
• Experience in the bio/pharmaceutical industry within Quality.
• Expertise in GDP, GMP, and QMS management.
• Demonstrated ability to work independently and in project settings to deliver objectives.
• Strong communication, influencing, and project management skills.
  

Why AstraZeneca?

At AstraZeneca, we are committed to being a Great Place to Work. We empower you to push the boundaries of science and unleash your entrepreneurial spirit. Here, you can make a tangible difference in medicine, patients, and society. Join our inclusive culture that champions diversity, collaboration, and lifelong learning, and be part of our exciting journey to pioneer the future of healthcare.

Apply today and take the next step in your career with AstraZeneca!