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. Your contribution will be visible, valued and central to getting innovative medicines to people who need them-safely, reliably and at pace. Lead Quality at Mount Vernon and set new standards for product assurance and regulatory excellence-take this opportunity to create lasting impact for patients and for your career. Date Posted 24-Jul-2026 Closing Date 09-Aug-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr