Senior Quality Auditor - Pharmaceutical/Supplier Audits

Advanz Pharma

London, United Kingdom

About the Role

In this role, you will support the lifecycle management of our global vendor and supplier network, ensuring compliance with EU GMP, EU GDP, and other applicable regulatory standards. You will lead risk-based audits - primarily of sterile manufacturing facilities—while mentoring team members and deputising for the Senior Quality Manager – Supplier Assurance as required.

This is a highly collaborative role, working closely with colleagues across Quality, Supply Chain, and Regulatory teams, and offers exceptional exposure to diverse suppliers, products, and global manufacturing operations.

What You’ll Do:

Conduct and lead risk-based audits of vendors and suppliers, with a strong focus on sterile manufacturing sites.
Monitor and maintain the vendor audit programme, ensuring compliance with EU GMP, EU GDP, and relevant MA requirements.
Perform risk-based assessments of audit outcomes and liaise with QPs and senior management on required actions.
Monitor and maintain internal and external CAPAs.
Maintain vendor validity within the SAP ERP system.
Evaluate and interpret global regulations to support audit activities.
Create, revise, and review QA audit documentation, including checklists, questionnaires, SOPs, and guidance documents.
Mentor team members and support capability development across the audit function.
Deputise for the Audit Manager as required.
Thrive in an entrepreneurial environment, and take accountability for results.
Embrace challenge and change, applying a growth mindset approach.
Have a bias for action and fast decision making.
Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity.
Drive the spirit of “One Team” through open, honest, and respectful collaboration across functions.
Contribute to making ADVANZ PHARMA a desired place to work.

About You

We are looking for a highly motivated Quality professional who is passionate about making a meaningful difference to patients’ lives through robust supplier assurance and high-quality manufacturing standards.

For this role, you will also have the following:

Qualifications:

Degree in Chemistry, Pharmacy, Microbiology, or equivalent.
General auditing qualification (essential).
External Lead Auditor qualification (essential).

Knowledge, Skills & Experience:

Working experience in a similar Quality Audit role within the pharmaceutical industry.
Essential: Proven experience auditing sterile manufacturing facilities.
Experience auditing external suppliers such as labs, distributors, and transport partners.
Strong understanding of EU GMP, EU GDP, and relevant global regulations.
Experience with CAPA management and risk-based decision making.
Ability to travel nationally and internationally at least twice per month.
Strong organisational, time-management, and multitasking skills.
Excellent written and verbal communication skills, including interacting with senior stakeholders at third-party suppliers.
Proven ability to work independently, remain calm under pressure, and manage competing priorities.
Logical, methodical approach to problem-solving with strong attention to detail.
Experience auditing medical devices or biosimilars (desirable).