Senior Quality Assurance Specialist

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 lead the charge in ensuring top-notch compliance and quality within our operations? As a Senior Quality Assurance Specialist, you'll be at the forefront of driving excellence and innovation in our processes. Your strategic leadership will be pivotal in managing compliance programs and overseeing core quality systems, ensuring our site meets the highest standards of GMP requirements. You'll have the opportunity to influence key stakeholders, lead inspections, and spearhead continuous improvement efforts. Are you prepared to make a significant impact?

Accountabilities:
Compliance Leadership
- Serve as primary point of contact for Regulatory Agency communications.
- Lead the 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 and identifying compliance gaps.
- Act as SME on Issues Management Teams, driving resolution of complex compliance issues.
- Lead/actively participate in site Quality Management Review and other Quality and Operations Forums.
- Design/develop/deliver site cGMP Training Programs as needed.
- Review/approve SOP changes, investigations, and CAPA.
- Lead projects or actively 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.
- Support validation/qualification and change control activities.

Quality Systems Processes Ownership
- Provide site-level process ownership 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, Site Master File, Product Reviews, Product Containment, and Quality Agreements.
- Manage quality system procedures and update as needed to ensure compliance.
- Manage accounts, system access, permissions for quality system applications.
- 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.
- Demonstrate strong collaboration with regional and global sites for consistent application of quality systems/processes.

Essential Skills/Experience:
- Bachelor’s degree in a science-based field
- Excellent oral and written communication skills
- Strong ability and motivation to learn
- Ability to collaborate and participate in multi-disciplinary teams
- 5 years industry experience and/or FDA experience with at least 3 years in Quality Assurance/Compliance
- Strong knowledge of global regulatory and cGMP requirements, industry best-practices
- Strong familiarity with production operations
- Strong leadership, project management, and 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
- 7+ years in QA/Regulatory Compliance in the pharmaceutical industry
- 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

At AstraZeneca, we are committed to making a real-life difference to patients through our Total Quality culture. Our focus on growth and innovation means there are always exciting opportunities to assure quality as we bring new products to market globally. With a clear strategy and ambition, we provide an environment where you can grow a fulfilling career while contributing to our Lean journey. Join us in our mission to deliver medicines safely and reliably.

Ready to take the next step in your career? Apply now and be part of our journey!

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.