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.

The Mt. Vernon site was established in 1972 and is the flagship site delivering innovative, life changing oral solid medicines. At the site we formulate and pack OSD tablets, capsules, powders and liquids to over 60+ markets. The Mt Vernon site is the largest AZ production site in the US and is located in the southwest corner of the state of Indiana, approximately 15 miles from Evansville, Indiana – the third largest city in the state of Indiana. The Mt. Vernon site is dedicated to creating a culture of inclusion and collaboration. We host yearly Inclusion and Diversity conferences and have an employee resource group devoted to promoting diversity and inclusion and enhancing employees' professional development through interactive and engaging events and initiatives.

We are a team of results-oriented people, who want to go far, and we’re all here to achieve. It’s what drives us to be proactive and solutions-focused. At every stage of production, we step up and take accountability to deliver, each of us feeling responsible for the outcomes. What we do is important and valued – we make a real-life difference to patients.

The Senior Compliance Specialist is responsible for providing both tactical and strategic leadership for Compliance and Quality activities within operations or sites.

What you’ll do:

• Lead the preparation, planning & logistics, inspection management, and response/follow-up for Customer and Regulatory Agency Inspections and serve as primary point of contact for Regulatory Agency communications.
• Collaborate with/Influence key operations customers to drive the site Compliance Improvement Program.  Provide compliance expertise to the site, consulting with customers and helping to identify compliance gaps, recommending compliance improvements or solutions for the supply site.
• Core team participant on Issues Management Teams, driving resolution of complex compliance issues.  Lead/actively participate in site Quality Council and other Quality and Operations Forums.
• Design/Develop/Deliver site cGMP site Training Programs as needed.  Review/Approve SOP changes.  Lead projects or actively participate on teams related to Compliance, Quality Systems, and continuous improvement initiatives.
• Provide site-level process ownership for the following core Quality Systems: Product Quality Complaints, Change Control, Quality Deviations, CAPA Management, Internal Audit Program, NDA Field Alert program/process, Local Supplier Management, Customer Quality Management (where the Mt. Vernon site is acting as a 3rd party supplier of products),  Site Master File, Product Reviews, Product Containment, Quality Risk Management, Implementation of revisions to global regulations/policies in the AZ Global Quality and Compliance Manual

Essential for the role:

Required:

• Bachelor’s degree in a Science/technical field such as Pharmacy, Biology, Chemistry or Engineering.
• Minimum of 5 years’ experience in Quality Assurance/Compliance with at least 3 years working extensively with FDA regulatory compliance audits.
• Strong knowledge of global regulatory and cGMP requirements, industry best-practices.  Strong familiarity with production operations.  Strong leadership, project management, and technical writing.
• Excellent oral and written communication skills.  Strong ability and motivation to learn.  Ability to collaborate and participate in multidisciplinary teams.
• Strong interpersonal, communication, and influencing skills.

Preferred:

• Pharmaceutical or medical device industry experience.
• 7+ years in QA/Regulatory Compliance.
• Prior experience leading/managing regulatory inspections.
• Experience managing Quality Systems
• ASQ certifications (e.g. CQA, CQE, CQM).
• Active member of pharmaceutical trade associations such as ISPE, PDA, 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, groundbreaking cutting edge 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!

To be considered for this great 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 an excellent fit, please share this posting with them.

Find out more on Social Media:

• LinkedIn https://www.linkedin.com/company/1603/
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• Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
• 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.