At AstraZeneca, we turn ideas into life-changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Quality Advisor in Durham, North Carolina, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast-paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries, we’re focused on supplying our medicines with care, quality, and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

The Quality Advisors are responsible for compliance decisions having an impact on AZ development projects and therefore AZ’s business and external reputation.  They use risk management to evaluate compliance issues and to develop solutions. The decisions are made against a background of regulations that vary depending on the stage of development and against a set of standards that require interpretation.

When working with project/supply chain teams, they are responsible for QA release of Drug Substance, Drug Product and Investigational Medicinal Product for clinical trials. When working with functions they are responsible for assuring that activities and processes across the development chain are delivered to appropriate standards to meet regulatory expectations and assure product integrity and acceptability. They interpret and trend compliance data to measure and improve quality standards. 

The role holders are expected to develop and maintain a knowledge of the quality regulations and guidelines applicable to their area.

Responsibilities:

• Provide QA input into internal/external manufacturing activities for Drug Substance and Drug Product, including: issue batch documentation and labels for GMP manufacture/packaging, supports on-the-floor manufacturing activities, supports manufacturing and packaging deviations and investigations.
• Responsible for QA release of Drug Substance, Drug Product and Investigational Medicinal Product for clinical trials including performing quality review of release documentation for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
• Responsible for developing and approving GMP and QA risk assessments and suggest mitigation activities and technical approaches to manufacturing for Drug Substance and Drug Product.
• Provide advice to support the development, implementation and continuous improvement of GMP quality systems across the development functions and support implementation of agreed global standards.
• Interpret, trend and report compliance data, to measure and improve quality standards within the development functions.
• Provide appropriate Quality Assurance input and advice to Pharmaceutical project teams and to business improvement projects.
• Notifies management of quality/compliance trends or failures.
• Support Issue Management Teams on specific issues.
• Responsible for QA approval of documentation related to manufacturing equipment and facilities to ensure compliance, including maintenance, calibration, validation and change control.
• Provide support and guidance to development functions to satisfy internal and external GMP inspections.

Internal/External Customers include: Pharmaceutical Development staff and leaders across all functions, for advice and decisions on QA matters, QA peers across all locations, networks with other Quality Assurance associates, across Operations Sites and Science Units, Quality professionals in the R&D Supply Chain external suppliers.

Qualifications:

Education:

• Bachelor’s degree required, however, in lieu of a Bachelor’s degree, an Associate’s Degree with a minimum of ten years’ experience in pharmaceuticals, GMP and in a quality role is required.

Required:

• Minimum of three (3) years experience in within a pharmaceutical GMP environment required.
• Broad and comprehensive understanding of Quality Systems and GMP is essential.
• Comprehensive understanding of the pharmaceutical/drug development process.
• Good knowledge and reputation in the QA arena and specifically in GMP matters.
• Understanding of Project Management processes

Preferred:

• Experience in Quality in a pharmaceutical development organization.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

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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.