Senior Director, Quality

Senior Director, Quality
 

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?
 

Accountabilities:

• Pharmaceutical Quality System Leadership: Implement, maintain, and continuously improve the site’s compliance profile; define and uphold the authority and independence of the Quality unit across the site.
• Release and Disposition: 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.
• Regulatory Engagement: 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.
• Quality Unit Governance: Ensure roles, responsibilities, and reporting lines are clearly defined to preserve a functionally independent Quality organization.
• People and Capability: 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.
• Management Review and Continuous Improvement: Sponsor the site Management Review to monitor the health of Quality Systems; drive continual improvement in product quality and GxP compliance.
• Strategy and Leadership: 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. 
• Cross-Functional Collaboration: Work with operations and other site functions to translate business objectives into quality outcomes without compromising quality principles.
• Budget and Resource Stewardship: Develop and execute Quality operating and capital budgets; control costs within approved levels while ensuring system effectiveness.
• Recall and Compliance Readiness: Act as Local Recall Administrator; ensure robust processes and readiness for effective field action when needed.
• Ethical Conduct and GxP Accountability: Foster a culture of compliance, ensure completion of required training, and provide appropriate resources to maintain and improve the Quality system.

Essential Skills/Experience:

• 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.

Desirable Skills/Experience:

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

Why AstraZeneca:

Here, Quality is the voice of the patient and a driving force for how we design, make and deliver medicines. You will help shape a forward-looking, science-led approach that pairs digital and Lean evolution with hands-on collaboration across sites and disciplines. We 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.