As a Senior Quality Assurance Specialist, you will interpret external regulatory standards into appropriate quality standards, provide guidance to project teams, and ensure compliance with AstraZeneca and Regulatory requirements. You will lead continuous quality improvement efforts in line with GMP regulations, support QA release of Drug Substance, Drug Product and Investigational Medicinal Product for clinical trials, and maintain internal controls over quality policies and procedures. You will also manage projects related to compliance of the quality system, development of new procedures and controls, and maintenance of established programs.

Essential Skills/Experience:
- Bachelor’s Degree, preferably in Life Sciences.
- Minimum of five (5) years of experience working in the pharmaceutical and/or biotechnology field with a focus on GMP environment.
- At least three (3) years of experience in quality assurance.
- Demonstrated knowledge of Quality Assurance activities and FDA/EU GxP regulations.
- Outstanding interpersonal, problem solving, and written/verbal communication skills.

Desireable Skills/Experience:
- Excellent team working and networking skills.
- Demonstrates independent judgement and uses risk management in complex situations.
- Capable of making decisions, acting courageously and communicating with conviction and inspiration.
- A good communicator with experience of interacting effectively across interfaces collaborating internally.
- Builds excellent relationships both internally and with external suppliers or service providers.
- Experience relating to clinical trials, product development, manufacturing, technology transfer, validation and qualification processes.

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 our entire shift onsite, 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.

Why AstraZeneca?
With constant new products and launches, there's never been a better time to join our Operations team at AstraZeneca. Here you can feel a strong connection to the patient. It's what drives us every day. We are united behind one mission: finding the best solution to put our patients first. Play a critical role in making this happen, delivering our innovative medicines all the way until they reach our patients. If you are driven, take smart risks and are able to act quickly, then this is the place for you. 

Ready to make a difference? Apply now to join our team!

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.