Senior Specialist, Quality - Clinical Supply Quality

AstraZeneca; Macclesfield; Hybrid; GBP 40,000 - 80,000; Full time

Job description

Senior Specialist, Quality - Clinical Supply Quality

Location: Macclesfield

Competitive salary and benefits

Introduction to Role:

Join us at AstraZeneca as a Senior Specialist, Quality in our Operations team. Be the voice of the patient and play a critical role in monitoring and signing off each batch of medicine as if it were for your own family. Your contributions will directly improve the quality of patients' healthcare and their quality of life.

Accountabilities:

As a Senior Specialist, Quality, you will be responsible for QA release of Drug Substance and Investigational Medicinal Product for clinical trials. You will provide Dev Q input to support Packaging, Labelling & Distribution of IMP as required. You will also support the delivery of QA activities for your assigned portfolio of projects. Your role will involve providing advice to support the development, implementation and continuous improvement of GMP quality systems across the development functions and support implementation of agreed global standards. You will interpret, trend and report compliance data, to measure and improve quality standards within the development functions. Lastly, you will provide appropriate Quality Assurance input to business improvement projects.

Essential Skills/Experience:

1. Appropriate scientific degree with significant years of experience of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organisation.
2. A broad understanding of Quality Systems and GMP is essential.
3. An understanding of the pharmaceutical/drug development process.

Desirable Skills/Experience:

1. Good team working and networking skills and encourages team effectiveness.
2. Demonstrates independent judgement and uses risk management.
3. Capable of making decisions, acting courageously and communicating with conviction and inspiration.
4. A good communicator with experience of interacting effectively across interfaces.
5. Builds good relationships both internally and with external suppliers or service providers.
6. Demonstrate drive and energy in the role to make a difference.
7. Demonstrates a high degree of personal credibility.
8. Experience of computerised systems validation or other validation/qualification activities.
9. Digital capabilities, for example proficient in platforms such as Microsoft Excel, PowerBI.

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.

Why AstraZeneca?

At AstraZeneca, our work is important and valued. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We are proactive, science-based, and solutions-oriented. Our focus is on scaling and introducing new technologies, using models to predict and proactively manage risk. We take Quality seriously and strive to add real value to a business throughout the lifecycle of our products. We are a team of ambitious people, who want to go far and we're all here to achieve.

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

Date Posted: 22-Apr-2025

Closing Date: 02-May-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.