At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost 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 for 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 Quality Facilitator is responsible for all Quality activities and decisions (end to end) that directly support execution of the Process Execution Team (PET) mission. These activities and decisions include batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, and regulatory interactions. This leadership role, reporting to the Sr. Director, Quality and the PET Leader (indirectly), is the single point of contact for all Quality matters related to PET execution (quality, supply, and cost) and the primary link between the PET and other QA/QC functions.

What you’ll do:

• Develop and maintain a high level of understanding of the technical production process and quality systems being utilized within the Process Execution Team (PET).
• Accountable for all Quality decision-making in the PET; works directly with the PET leader and other PET members to deliver all PET objectives.
• Provides direction, development, and performance management to the Quality professionals supporting the PET; serves on the site Quality Leadership Team (QLT).
• Performs the Quality review and approval of the following GMP documentation that has direct impact on the activities performed by, and the equipment and facilities utilized by the PET:
  • Change Requests
  • Batch Release decisions including Stop Shipments
  • Quality Investigations (Deviations, Product Complaints)
  • Validation Plans, Protocols, and Reports
  • Standard Operating Procedures
• Collaborates with Quality facilitators and Quality professionals from other PETs (including other sites) to ensure consistent application of the key quality systems across all PETs.
• Interfaces with the Site Support Groups on improvement projects (capital and non-capital) that impact the PET, and proactively ensures GMP compliance during the planning, execution, and closeout phases of these projects.
• Provides support to internal audits and regulatory agency inspections for queries relating to process execution activities.
• Ensures that PET complies with all GMP Compliance and Regulatory requirements by providing proper coaching, mentoring, and consultation to the PET leader and PET members.
• Ensures QA processes including batch record review, product disposition, and quality issues resolutions are executed to maintain the flow of products and documents to meet PET objectives.
• Serves as liaison in discussions and agreements with, and ensures timely communication to, other Quality functions at the Site (Compliance and QC Labs).
• Serves as the liaison to global AZ supply sites and quality organizations; may also serve as Quality representative to U.S. product supply teams.

Essential for the role:

• Bachelor’s degree in a science/technical field such as Pharmacy, Biology, Chemistry or Engineering or other science related field.
• Minimum of 10 (ten) years of pharmaceutical industry experience with 5+ years of relevant Quality Assurance Experience including supervision.
• Advanced knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies.
• Advanced knowledge of regulatory agency interactions and compliance procedures, with ability to apply the knowledge in an operations environment.
• Demonstrated ability to influence leaders in a matrix environment and the personal conviction to make courageous decisions to ensure patient safety and to protect company reputation.

Preferred Requirements:

• Ten years of experience in supervisory/managerial roles within QA in the Pharmaceutical Industry
• Advanced degree such as a Master’s degree or higher.
• Lean Six Sigma experience.
• Cross functional and diverse experience within various Quality disciplines (Ex. QA, Compliance, Validation, etc…) or within other areas of the organization (Ex. Operations, OpEx, 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. 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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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.