Associate Director Quality Assurance
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.
It is important to us that each employee feels welcome to bring their whole self to work every day. Here is a sneak peek of some of “perks” the MTV site offers: on-site fitness center with access to a personal trainer, on-site walking trail, walking desk, on-site basketball court, ping pong, massage chair, lunch & learns, sustainable & ergonomic office working environment, tuition reimbursement, training/ lifelong learning opportunities, book club, dining center with hot meals, snack market, free coffee and hot tea, climate controlled work environment.
The Associate Director, Quality Assurance is responsible for providing both tactical and strategic leadership for Compliance and Quality Systems (QS) activities within operations or sites. This role involves managing critical Compliance and QS programs, ensuring the site meets current GMP requirements of all local/global regulations and internal AZ Quality and Compliance policies. You will drive continuous improvement efforts by evaluating site systems and processes against current Compliance and Quality Systems requirements, influencing key stakeholders on recommended Compliance improvements. Additionally, you will provide active support during inspections by External Customers, internal assessors, and Regulatory authorities.
Accountabilities
- May have direct report responsibilities.
- Demonstrate strong knowledge and expertise in all major responsibilities and processes of the role.
- Act as execution lead/process owner for one or more processes.
- Perform all tasks related to a Senior Specialist, Quality Assurance.
- Champion quality and compliance; maintain current knowledge of regulatory and industry trends and communicate these to colleagues.
- Lead/driving step change improvements to quality systems/processes through cross-functional project teams.
- Expert level understanding of cGMPs and Quality Systems.
- Influence and negotiate at all levels of the organization: globally and inside and outside of QA to deliver significant improvements in quality/compliance.
- Develop others by coaching/mentoring.
- Represent AstraZeneca interest in pharmaceuticals professional associations, discussions groups, etc.
- Support the preparation, planning, logistics, inspection management, and response/follow-up for Customer and Regulatory Agency Inspections.
- Collaborate with/influence key operations customers to drive 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.
- Drive 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.
- Provide guidance for the Data Integrity Program, Self-Inspection Program, and the Quality Risk Management Program.
- Lead and/or participate in Regional and Global Forums.
- Lead projects or actively participate on teams related to Compliance, Quality Systems, and continuous improvement initiatives.
- Supply/coordinate site documentation needed for new/revised Regulatory filings.
- Implement revisions to global regulations/policies in the AZ Global Quality and Compliance Manual.
- Support validation/qualification and change control activities.
- Support Compliance Director as designee or backup for various functions and actions as applicable and appropriately trained.
Essential Skills/Experience
- Bachelor’s degree in a Science/technical field such as Pharmacy, Biology, Chemistry or Engineering.
- Excellent oral and written communication skills.
- Strong ability and motivation to learn.
- Ability to collaborate and participate in multi-disciplinary teams.
- 7 years industry experience.
- Expert knowledge of global regulatory and cGMP requirements, industry best-practices.
- Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional teams. Strong familiarity with production operations.
- Strong leadership, project management, and technical writing.
- Strong interpersonal, communication, and influencing skills.
Desirable Skills/Experience
- 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, etc.
At AstraZeneca, we believe in empowering our teams to foster a Lean mindset and sustainable practices. We pioneer new approaches across our sites to deliver better outcomes for our patients. Our adaptable and agile environment encourages diverse expertise, cross-functional collaboration, and continuous improvement. We value every team member's voice, building trust and respect to ensure our people are supported in their roles.
Join us at AstraZeneca where your expertise can make a real difference! Apply today to 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.
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