Quality Assurance Specialist, External Quality

Job Title: Quality Assurance Specialist, External Quality

Introduction to role

Are you ready to make a difference in the world of biopharmaceuticals? As a Quality Assurance Specialist for External Quality, you'll play a pivotal role in ensuring the highest standards of quality in drug substance, drug product, and finished product manufacturing processes. With management support, you'll oversee quality activities at contract manufacturing organizations, guiding projects to completion and supporting ongoing quality assurance responsibilities. Your expertise will be crucial in maintaining compliance with industry standards and regulatory requirements, while also providing guidance to lower-level personnel. If you're passionate about quality and eager to contribute to life-changing medicines, this is the opportunity for you!

Accountabilities

What you'll do:

- Serve as Quality Assurance support and SME for Drug Substance, Drug Product and Finished product manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant
- Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to Drug Substance, Drug Product and Finished Product.
- Provides oversight to continuous quality system improvements and supports implementing improvements at CMO's in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as they impact Alexion
- Works closely to build relationships with contract manufacturers quality personnel
- Works closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events
- Responsible for reviewing contractor documents such as Batch records, deviations, and change controls to ensure they align with Alexion procedures and meet Alexion standards
- Approve Alexion specific standard operating procedures and controlled documents issued by contract manufacturing organisations
- Support contract manufacturing organisation audits, including pre-approval inspections, as necessary
- Develop and issue quality metrics pertaining to the process quality activities
- Trends and analyses quality aspects of technical transfer activities to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation, compiles and presents analyses at Quarterly Management Review meetings, proposes and leads team implementation of appropriate CAPA
- Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending
- Review Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness
- Represents Quality Assurance to guide various projects and technical meetings, as needed
- Responsible for documenting and reporting compliance issues to management
- Any other duties as required by management.

Essential Skills/Experience

- Must have experience/knowledge of drug substance, drug product and finished product manufacturing processes in a cGMP environment
- Proficiency in industry standard methodology and up-to-date knowledge of regulatory expectations for drug substance, drug product, and finished product manufacturing are essential. Minimum of 2-5 years' GMP related experience in biopharmaceutical / pharmaceutical or related industry
- Experience working with contract manufacturing organisations
- Ability to provide project leadership and guide successful completion of Quality projects
- Excellent written and verbal communication and negotiating skills
- Risk assessment and risk management
- Ability to exercise judgment with defined procedures and practices to determine appropriate action
- Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment
- Ability to monitor and report on assigned tasks, goals, and objectives.

Desirable Skills/Experience

Bachelor’s degree required; preference given to candidates with advanced degrees; 2 or more years cGMP experience preferred; consideration will be given to other relevant experience and education.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you'll find an environment where innovation thrives! Our commitment to rare diseases means your work will have a profound impact on patients' lives. With a rapidly expanding portfolio, you'll enjoy the entrepreneurial spirit of a leading biotech while being supported by exceptional leaders. Here, your career is not just a path but a journey towards making a difference where it truly counts.

Ready to embark on this exciting journey? Apply now!

Date Posted

27-Aug-2025

Closing Date

05-Sep-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca 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.