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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world's most serious diseases. But we are more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We're curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We're driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you'll do work that has the potential to change your life and improve countless others. And, together with your team, you'll shape a culture that unites and inspires us every day. 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