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Quality assurance new products introduction lead

Dublin
AstraZeneca
Posted: 5 July
Offer description

Quality Assurance New Products Introduction Lead Join to apply for the Quality Assurance New Products Introduction Lead role at Astra Zeneca Continue with Google Continue with Google Quality Assurance New Products Introduction Lead2 days ago Be among the first 25 applicants Join to apply for the Quality Assurance New Products Introduction Lead role at Astra Zeneca 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 c GMP 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 c GMP Quality environment and 5 years in a relevant QA or Technical managerial role.
Thorough knowledge of c GMPs, 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 c GMP experience preferred.
Consideration will be given to other relevant experience and education.
At Astra Zeneca, 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 healthcareDate Posted20-Jun-2025 Closing Date01-Jul-2025 Our mission is to build an inclusive and equitable environment.
We want people to feel they belong at Astra Zeneca and Alexion, starting with our recruitment process.
We welcome and consider applications from all qualified candidates, regardless of characteristics.
We offer reasonable adjustments/accommodations to help all candidates to perform at their best.
If you have a need for any adjustments/accommodations, please complete the section in the application form.
Seniority level Seniority level Director Employment type Employment type Full-time Job function Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Astra Zeneca by 2x Sign in to set job alerts for "Quality Assurance Lead" roles.
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