Associate Director Quality Assurance

Job Description

Job Title: Associate Director Quality Assurance

Location: Macclesfield, UK

Introduction to role:

We have an exciting opportunity for an eligible Qualified Person (QP) to join our Quality team. Ideally you should have aseptic knowledge and a desire to expand into new asset and aseptic process establishment. As an Associate Director of Quality Assurance, you will support innovative programmes across our aseptic manufacturing areas and have the opportunity to manage a team of Quality and Environmental Assurance professionals working cross functionally with manufacturing.

You will take the lead in major aseptic quality enhancements and general day-to-day issue resolution within the plants you are aligned to, ensuring that the highest aseptic and compliance standards are maintained. This role is a fantastic opportunity to accelerate our Lean journey and drive efficiencies in our processes, producing better-quality outputs.

Accountabilities:

As an Associate Director of Quality Assurance (QA), your responsibilities will encompass several key activities. You will adhere to all critical policies and procedures while managing people in accordance with the Manager Accountability Framework.

Your key accountabilities include:

• Proactively reinforcing quality principles.
• Resolving quality issues within the plant.
• Representing the QA function at project meetings.
• Maintaining and providing visibility of quality KPIs.
• Making decisions regarding aseptic assurance, product, and material release.
• Ensuring compliance with change management processes.
• Planning and leading preparations for internal and external inspections.
• Providing expert advice on Aseptic Assurance and Good Manufacturing Practice.
• Leading formal and informal training for less experienced staff and new starters.
• Actively seeking opportunities to identify and manage change.
• Reviewing Product Quality Reviews.
• Promoting a culture of no harm, hurt, or alarm.
• Ensuring compliance for yourself and others with internal and external regulations.
• Always maintaining a focus on customer service.
• Promoting a cost-conscious environment to facilitate effective cost management.
• Ensuring that all work is carried out in accordance with approved and established processes and procedures.

Essential Skills/Experience:

• Degree or equivalent professional qualification in a science / technical field such as Pharmacy, Chemistry or Biology.
• Eligible QP.
• Prior experience and expertise of sterile manufacturing/ sterility assurance within complex manufacturing processes. including isolator technology.
• A high level of technical process understanding, qualification and validation.
• Comprehensive knowledge of and application of quality systems.
• In-depth working knowledge of SAP.
• Management of a complex and changing workload.
• Management experience.
• Strong influencing skills across all levels of the organisation.
• Knowledge of other areas of the supply chain.
• Experience of working cross-functionally across the supply chain.

Desirable Qualifications:

• Managerial / Supervisory experience.
• Experience of working in a Lean environment.

At AstraZeneca, we take Quality seriously. 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, solutions-oriented, and it's our ambition that keeps pushing us forward. We are strong communicators and networkers. We get our pipeline out to patients sustainably, reliably and safely.

Here each voice matters and it instils a real sense of camaraderie. We take personal responsibility for the medicines. We have a clear ambition to shift the mindset around Quality. It's more than just following procedures and regulations; it's about adding value for our patients, which ultimately benefits the business.

Are you ready to make a real-life difference to patients? Apply now and join us in our journey to add real value to a business throughout the lifecycle of our products!

Date Posted

11-Sept-2025

Closing Date

25-Sept-2025Our 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.