Senior Director, Quality

AstraZeneca • Mount Vernon, IN

17h • Onsite

About The Position

Are you ready to pioneer a modern Quality mindset that safeguards patients while accelerating delivery? As Senior Director, Quality for our Mount Vernon site, you will lead the end-to-end Quality function that releases every batch, from raw materials to finished product, ensuring cGMP compliance and reliable, quality supply to patients. In this high-impact role, you will set the vision and standards for a functionally independent Quality unit, steer regulatory and compliance strategy, and partner closely with manufacturing and supply leaders to deliver safe, effective medicines with confidence. You will coach and empower a large, multi-disciplinary Quality team, apply evidence and data to decisive actions, and strengthen the systems that keep our operations robust and inspection-ready. Imagine bringing bold, science-backed decisions to the moments that matter most—how would you raise the bar for product quality and regulatory excellence across a complex, fast-moving, strategically important site?

Requirements

• Bachelors’ degree in a scientific discipline (e.g., Chemistry, Microbiology, Chemical Engineering).
• A minimum of 10 years’ experience in the pharmaceutical industry.
• A minimum of 3 years’ experience in a significant, supervisory capacity.
• In office attendance 5 days per week.
• A working knowledge of cGMPs and Food and Drug laws and regulations.
• Excellent oral and written communications skills.
• Well-developed interpersonal and problem-solving skills.
• Excellent leadership and organizational skills.
• Experience in interpreting and analyzing data so that decisions can be made on product quality.

Nice To Haves

• Pharmaceutical / Manufacturing operations background.
• Multiple experiences within pharmaceutical QA and/or operations.
• Experience in dealing with Regulatory Agencies (e.g., FDA, MHRA, ANVISA).

Responsibilities

• Implement, maintain, and continuously improve the site’s compliance profile; define and uphold the authority and independence of the Quality unit across the site.
• Oversee Quality release of raw materials prior to use and finished products prior to distribution; ensure delegates for release are appropriately trained and qualified; serve as accountable owner for Product Disposition.
• Serve as the primary site contact for health authority inspections (e.g., FDA, MHRA); lead responses to inquiries, facilitate investigations, and maintain strong agency relationships.
• Ensure roles, responsibilities, and reporting lines are clearly defined to preserve a functionally independent Quality organization.
• Lead, develop, and mentor Quality leaders and professionals; build deep product and process knowledge; ensure sufficient, trained resources to execute GxP obligations and sustain professional development.
• Sponsor the site Management Review to monitor the health of Quality Systems; drive continual improvement in product quality and GxP compliance.
• Partner with site leadership on short- and long-term strategies that prioritize Safety, Quality, Supply, Cost, and People; work alongside the Regional AQLT to develop and execute strategies to successfully navigate an evolving U.S. and global regulatory environment while serving as a key leader on the Americas Quality Leadership Team.
• Work with operations and other site functions to translate business objectives into quality outcomes without compromising quality principles.
• Develop and execute Quality operating and capital budgets; control costs within approved levels while ensuring system effectiveness.
• Act as Local Recall Administrator; ensure robust processes and readiness for effective field action when needed.
• Foster a culture of compliance, ensure completion of required training, and provide appropriate resources to maintain and improve the Quality system.

Benefits

• Quality is the voice of the patient and a driving force for how we design, make and deliver medicines.
• Help shape a forward-looking, science-led approach that pairs digital and Lean evolution with hands-on collaboration across sites and disciplines.
• Bring diverse experts together to solve real problems quickly, value kindness alongside ambition, and empower leaders to make brave, evidence-based decisions that protect patients and strengthen our pipeline.
• Your contribution will be visible, valued and central to getting innovative medicines to people who need them—safely, reliably and at pace.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior