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 exceptional skills with those of people from all over the globe.

Our West Chester Supply Site is a very dynamic and growing manufacturing site within the AstraZeneca Global Operations network and is located just north of Cincinnati, Ohio. In addition to serving as the global COVID vaccine production site for AstraZeneca, the West Chester site encompasses Bulk API Microsphere manufacturing, Aseptic Pharmaceutical Formulation, multi-line Isolator/Barrier Vial and Syringe Filling, and specialty Packaging Operations for Vials and Auto-Injectors that supports growing franchises in Diabetes, Respiratory, and Vaccines. Our site is one of 30 production facilities in 18 countries with over 700 people collaborating to connect powerful medications to patients in more than 60 countries around the world. We focus on providing a collaborative environment where everyone feels comfortable and able to be themselves. Being able to 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

What you'll do:

The Inspection Manager is responsible to prepare the site for external inspections including conducting mock inspections, supporting the internal audits of GMP functions and activities performed at WCH Site. This role allows an individual to be empowered to identify areas of opportunities,  implement program improvements, and provide expert advice on regulatory requirements.

The core responsibilities of the role are as follows:

• Develop and maintain the site inspection readiness plan, including communication channels, logistics, roles and responsibilities, etc.
• Ensure the site Audit and Inspection Program is suitable and effective to advance compliance with GxP.
• Identify and mitigate compliance risks to AZ WCH site through effective mock inspections and self-assessments.
• Support the Self-Inspection Program. Identify and incorporate to the program any changes to regulatory expectations and new GMP trends.
• Establish and monitor improvement processes, as needed, or set specific measurable targets and goals linked to the Self-Inspection program and inspection readiness plan.
• Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments.  
• Make recommendations for corrective and preventative actions related to inspection readiness.
• Build and maintain effective internal AZ business relationships within operational and support units.
• Contribute to the training, education, guidance and influencing of operational and support areas on quality and compliance policy and practices.
• Influence key stakeholders on recommended Compliance improvements.
• May have direct reports

Essential for the role:

• Bachelor’s degree in a Science/technical field such as Pharmacy, Biology, Chemistry or Engineering.
• 7 years of experience in the pharmaceutical industry
• Prior experience leading/managing regulatory inspections or self-inspection program.

Desirable for the role:

• 10+ years in QA/Regulatory Compliance in the pharmaceutical industry.
• Experience managing Quality Systems.
• ASQ certifications (e.g. CPGP, CQA, CQE, CMQ).
• Active member of pharmaceutical trade associations such as ISPE, PDA, etc.
• Experience in Quality Systems (e.g. Veeva Vault, TrackWise, etc.).

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, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey!

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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About Operations https://www.youtube.com/watch?v=gak5Ham8oUw

Date Posted

Closing Date

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.