Are you ready to lead the charge in ensuring top-notch quality for new product introductions? As the Quality Assurance New Product Introduction (NPI) Lead, you'll be at the forefront of overseeing all Quality Assurance Operations systems necessary for the successful integration of new products and technologies at our multi-product College Park facility in Dublin. Your role will encompass both Bulk Drug Substance and Packaging Operations, ensuring compliance with cGMP standards and regulatory requirements. You'll play a pivotal role in commissioning, verification, technical transfer, operational readiness, process validation, and inspection readiness, all while maintaining the highest quality standards for our products.
Accountabilities
In this dynamic position, you'll foster a culture of quality excellence, manage a QA team, and lead cross-functional teams to ensure compliance with change management, risk management, and deviation management. You'll collaborate proactively with various departments to resolve issues and contribute to quality improvement programs. Your responsibilities will include reviewing deviations, approving CAPAs, overseeing technical services and technical transfer, and leading QA efforts in manufacturing operations. You'll also represent Quality Assurance at project meetings and provide support to QC Microbiology. Your leadership will ensure site-wide implementation of Quality Systems to meet GXP and Alexion requirements.
Essential Skills/Experience
- Minimum of 10 to 15 years’ experience in cGMP Quality environment and 5 years in a relevant QA or Technical managerial role.
- Thorough knowledge of cGMPs, GLPs, GDPs and regulatory requirements
- Strong awareness and understanding of pharmaceutical and biotechnology business, especially with regards to quality and regulatory requirements
- Demonstrated success establishing and managing a QA organization with multi-level reporting structure and providing support to 24/7 manufacturing operations.
- Excellent people management, problem solving, decision-making skills and the ability to manage a broad portfolio of activities in an environment where priorities can change.
- Ability to successfully lead a Quality Organisation and partner with Operations.
- Strong leadership, communication and interpersonal skills with a lean-thinking mindset.
Desirable Skills/Experience
- BSc/BA degree in chemistry, biological science or related field.
- 10 or more years of cGMP experience preferred. Consideration will be given to other relevant experience and education.
At AstraZeneca, we are driven by a passion for innovation and a commitment to making a difference in the lives of patients. Our unique culture fosters collaboration, creativity, and growth, allowing you to thrive in an environment where your contributions truly matter. With a rapidly expanding portfolio and a focus on rare diseases, you'll have the opportunity to work alongside exceptional leaders and peers who are dedicated to transforming healthcare. Join us in our mission to change lives for the better, every day.
Ready to make an impact? Apply now and be part of our journey to redefine healthcare!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
