AstraZeneca

The AstraZeneca 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 and capsules for over 60+ markets. The Mt Vernon site is complex, the largest AZ production site in the US with over 700+ employees. We are located in the southwest corner of the state of Indiana, approximately 15 miles from Evansville, Indiana – the third largest city in the state. The Mt. Vernon site is both collaborative and Inclusive. We have several employee resource groups (ERGs) onsite that are aimed at promoting, celebrating, and educating employees about diversity, inclusion, philanthropy, networking, etc. Each of these groups provide employees with opportunities for interactive and engaging events and initiatives which enhance professional development and provide opportunities to engage with likeminded co-workers.

Are you ready to pioneer a new Quality way? As a Specialist Pharmaceutical Quality Systems, you'll be at the forefront of ensuring compliance and quality within our operations. This role is crucial in supporting all Compliance programs and executing activities that align with current GMP requirements and AstraZeneca's internal Quality and Compliance policies. You'll be instrumental in supporting various Quality Systems processes, driving continuous improvement efforts, and facilitating inspections by external customers and regulatory authorities.

Accountabilities:

Compliance Leadership

• Support preparation, planning, logistics, inspection management, and response/follow-up for Customer and Regulatory Agency Inspections.
• Collaborate with key operations customers to drive the site Compliance Improvement Program.
• Provide compliance expertise to the site, consulting with customers to identify compliance gaps and recommend improvements.
• Participate in site Quality Management Review and other Quality and Operations Forums.
• Design, develop, and deliver site cGMP Training Programs as needed.
• Review and approve SOP changes, investigations, and CAPA.
• Participate on teams related to Compliance, Quality Systems, and continuous improvement initiatives.
• Implement revisions to global regulations/policies in the AZ Global Quality and Compliance Manual.

Quality Systems Processes Support

• Provide site-level process support for core Quality Systems such as Product Quality Complaints, Change Control, Quality Deviations, CAPA Management, Internal Audit Program, NDA Field Alert program/process, Local Supplier Management, Customer Quality Management, Product Reviews, and Quality Risk Management.
• Manage the quality system to ensure consistent application across the site.
• Collaborate with other sites to create standard quality systems requirements where possible.
• Execute data queries/analyses and publish periodic trend reports.
• Provide routine reports for regulatory documents, inspections, or focus teams.

Essential Skills/Experience:

• Bachelor’s degree in a science-related field
• Excellent oral and written communication skills
• Strong ability and motivation to learn
• Ability to collaborate and participate in multi-disciplinary teams
• 3 years industry experience and/or FDA experience
• Knowledge of global regulatory and cGMP requirements, industry best-practices
• Familiarity with production operations
• Strong technical writing
• Strong interpersonal, communication, and influencing skills

Desirable Skills/Experience:

• Bachelor’s degree in a Science/technical field such as Pharmacy, Biology, Chemistry or Engineering
• 2+ years in QA/Regulatory Compliance in the pharmaceutical industry
• Experience with Quality Systems

At AstraZeneca, we are committed to making a real-life difference to patients through our Total Quality culture. Our forward-looking mindset empowers us to innovate and trial the latest models and technologies to improve reliability and excellence in our processes. We foster an inclusive community where each voice matters, encouraging collaboration across sites and regions. With a focus on growth and innovation, AstraZeneca offers constant opportunities for career development as we introduce new products and technologies.

Ready to take accountability and make brave decisions? Apply now to join our team at AstraZeneca!

Date Posted

06-May-2025

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.