Senior Auditor

Introduction to role:

Are you ready to take on a challenging role that requires audit skills and digital acumen? We are now recruiting for a Senior Auditor at AstraZeneca, to conduct audits of manufacturing sites, contractors, and more, ensuring compliance with local and international regulations. This opportunity requires a strong background in performing audits, with expertise in interpreting and applying cGMP requirements. As AstraZeneca leads digital innovation in pharmaceutical manufacturing, you'll play a crucial role in appraising quality and compliance systems throughout our supply chain, ensuring they meet risk-based requirements.  

Accountabilities:

This opportunity would suit an individual with GMP audit experience who is looking to become a "digital advocate" in a Quality auditor role.

• Conduct independent appraisals of quality and compliance systems within technically advanced manufacturing settings.

• Perform complex domestic and international audits of suppliers of chemicals, packaging components, finished drug products, or contracted services in accordance with cGMPs, ISO Standards, IPEC, ICH Q7A, and company procedures.

• Plan, coordinate, and conduct scheduled or unscheduled cGMP audits of complex internal AstraZeneca Operational departments to ensure compliance with CGMPs and AstraZeneca standards, including developments in digital and artificial intelligence-related technologies.

• Provide clear and scientifically/technically explained interpretations and support for any audit findings and proposed corrective and preventive actions.

• Liaise directly with local AZ and/or regional and global senior management to ensure issues are understood and proposed actions are acceptable.

• Interpret and apply cGMP regulations and expectations, including in the context of pharmaceutical innovation.

• Demonstrate validated written and oral skills with experience working in cross-cultural settings.

• Initiate and maintain close contacts with regulatory agencies and/or industry/professional organisations to stay aware of trends and initiatives in quality assurance, GMP compliance, and inspections.

• Develop and interpret audit findings across the scope of the Global Quality Audit (GQA) to communicate trends and provide recommendations proactively.

• Work closely with QA colleagues to assure understanding of developing interpretations of cGMP while maintaining independence.

• Ability to utilise AI for predictive compliance analysis and auditing

Essential Skills/Experience:

• Ideally you will have a background in either Quality, Operations, Engineering or IT and have worked in environments governed by GMP standards - audit experience is required

• Bachelor's degree or equivalent experience in a scientific field

• Self-directed and highly motivated teammate with solid organisational capabilities

• Cross-cultural awareness and sensitivity

• Excellent written and verbal communication skills, with an ability to manage stressful and confrontational situations to positive outcomes

• Proven ability to continually refresh cGMP interpretation and application through self-study and external involvement with industry groups

• Solid knowledge of modern quality systems, risk assessment, corrective and preventive action development and execution, and other evolving principles across the global compliance arena

• Direct and increasingly responsible audit responsibilities

• Solid awareness of functional areas such as product development

• Curious regarding evolving AI technology with an interest for self development and initiation in this role

Desirable Skills/Experience:

• Experience in other GXP areas (GLP, GCP)

• Overseas auditing experience

• Pharmaceutical industry background with GMP knowledge

This role will be based out of Macclesfield with extensive travel 40-60% of the time both regionally and internationally.

AstraZeneca offers an environment where your work is valued and impactful. With a forward-looking attitude, you'll be at the forefront of innovation, trialling the latest models and technologies to improve reliability and excellence in our processes. Here, you'll feel empowered to make decisions that put patients first. Our inclusive community fosters collaboration across sites and regions, sharing expertise to drive our modern mindset forward. With constant growth comes responsibility, offering you exposure to new products, technologies, and growing areas like biologics. It's a place where you can grow a fulfilling career while making a real-life difference to patients.

Ready to take on this exciting challenge? Apply now to join our team at AstraZeneca!

Date Posted

17-Nov-2025

Closing Date

30-Nov-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.