Director, Manufacturing Site Quality- West Chester, OH- Global Operations

Would you like to apply your expertise to impact the Quality Operations in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca, we continuously forge partnerships that help pursue extraordinary medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe. Working here means being results-oriented, thinking big and working together to make the impossible a reality. We’re passionate about the potential of science to address the unmet needs of patients around the world. We commit to those areas where we believe we can really change the course of medicine and bring big new insights to life. With 30 production facilities in 18 countries we’re passionate about supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Come and thrive in our vibrant, energizing, connected and encouraging 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

As Director of Site Quality for our West Chester, OH facility, you’ll efficiently deliver the Quality Control of the Manufacturing Plan on time to the required standards of Good Manufacturing Practice, Safety Healthy and Environmental and Compliance. You’ll play a pivotal part in owning the cost of delivery of Quality Assurance and Quality Control to at the site.

At AstraZeneca’s West Chester, Ohio, facility we focus on providing a collaborative environment where everyone feels comfortable and able to be themselves. Being able bring your full self to work every day is at the core of AstraZeneca’s priorities. On-site amenities include a Health and Wellness clinic, as well as a Cafeteria Grille serving breakfast and lunch items for employees and guests. We also have a Great Place to Work Counsel, involving committees of employees who coordinate several activities related to Community Outreach, Sustainability, Health and Wellness and Social Events.

Reporting to the Head of Quality Supply America’s, the Site Quality Lead is responsible for quality for the West Chester Facility and will lead a team of 96 employees. The role will form part of the site leadership team as well as part of the America’s Quality Leadership team.

What you’ll do:

• Establishes strategy for ensuring Quality Management Systems are implemented and maintained in accordance with applicable AstraZeneca Global Quality Operations guidelines, procedures, and strategy as well as external regulatory agency requirements.
• Set strategic direction for quality within that area, maintaining quality oversight and assurance of appropriate standards, and driving continuous improvement.
• Responsible for QA review, approval, and Quality operational oversight of internal manufacturing documentation, defining and agreeing on the follow up of corrective and preventative actions from changes and deviations during manufacture.
• Be responsible for the delivery of QA activities for their assigned portfolio of projects. Accountable for aligning all QA activities across a project and empowered to resolve any project quality issues across the QA sections.
• Support a strong lean culture that promotes standardization, simplification and continuous improvement

Essential for the role

• Bachelor’s Degree in appropriate scientific field.  Master’s degree desirable. 
• Minimum of 15 years of working within a pharmaceutical GMP environment, preferably within a sterile or aseptic environment.
• A broad and comprehensive understanding of Quality Systems and GMP.
• An all-inclusive understanding of the pharmaceutical/drug development process.
• Solid understanding and experience in the development and manufacture of combination device products.
• Understanding of Project Management, Supply Chain and LEAN processes
• Proven leadership and excellent communication skills.

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 entrepreneurial -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 cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Wonderful! We have one seat available and we hope it’s yours.

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 phenomenal 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.