Associate Director Pharmaceutical Quality Systems (Compliance)

Associate Director Of Pharmaceutical Quality Systems (Compliance)

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.

Are you ready to lead the charge in pharmaceutical quality systems and compliance? As the Associate Director of Pharmaceutical Quality Systems (Compliance), you'll provide both tactical and strategic leadership within operations or sites. Your mission is to manage critical compliance and quality systems programs, ensuring adherence to GMP requirements and driving continuous improvement efforts. You'll be at the forefront, influencing stakeholders and supporting inspections by external customers, internal assessors, and regulatory authorities. Are you prepared to make a significant impact?

Accountabilities : Compliance Leadership - May have direct report responsibilities - Demonstrated strong knowledge and expertise in major responsibilities and processes - Act as execution lead / process owner for one or more processes - Perform tasks related to a Senior Compliance Specialist - Champion of quality and compliance; communicate regulatory and industry trends - Lead / driving improvements to quality systems / processes through cross-functional teams - Expert understanding of cGMPs and Quality Systems - Influence and negotiate at all organizational levels globally - Develop others through coaching / mentoring - Represent AstraZeneca in pharmaceuticals professional associations - Support preparation, planning, logistics, inspection management, and follow-up for inspections - Collaborate with / influence key operations customers for site Compliance Improvement Program - Provide compliance expertise, consulting with customers to identify gaps and recommend solutions - Drive resolution of complex compliance issues - Lead / participate in site Quality Management Review and other forums - Design / develop / deliver site cGMP Training Programs - Review / approve SOP changes - Guide Data Integrity Program, Self-Inspection Program, and Quality Risk Management Program - Lead / participate in Regional and Global Forums - Lead projects or participate on teams related to Compliance, Quality Systems, and improvement initiatives - Supply / coordinate site documentation for new / revised Regulatory filings - Implement revisions to global regulations / policies in AZ Global Quality and Compliance Manual - Support validation / qualification and change control activities - Support Compliance Director as designee or backup

Essential Skills / Experience : Bachelor's degree - Excellent oral and written communication skills - Strong ability and motivation to learn - Ability to collaborate and participate in multi-disciplinary teams - 7 years relevant experience in industry - Expert knowledge of global regulatory and cGMP requirements, industry best-practices - Demonstrated ability to work independently and collaboratively on multidisciplinary teams - Strong familiarity with production operations - Strong leadership, project management, and technical writing skills - 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, etc.

AstraZeneca offers an environment where quality is paramount. With a forward-looking mindset, we are at the forefront of innovation, trialling the latest models and technologies to enhance reliability and excellence. Our commitment to patient-centricity drives us to deliver medicines safely and sustainably. Here, you'll find an inclusive community that values collaboration across functions and regions. Join us as we accelerate our Lean journey, taking advantage of opportunities to drive efficiencies and produce better-quality outputs.

Ready to make a difference? Apply now to join AstraZeneca's dynamic team!