Senior Quality Auditor - Pharmaceutical / Supplier Audits
Join ADVANZ PHARMA as a Senior Specialist Quality Auditor to support the lifecycle management of our global vendor and supplier network, ensuring compliance with EU GMP, EU GDP, and other applicable regulatory standards.
Date: 24 Nov 2025
Location: GB, EC4N 7BL
Company: AdvanzPharma
Job Title: Senior Specialist Quality Audits Sterile Manufacturing
Hybrid: 2 days per week on-site, with regular international travel
About the Role
In this role, you will lead risk‑based audits primarily of sterile manufacturing facilities, mentor team members and deputise for the Senior Quality Manager – Supplier Assurance as required. You will work collaboratively across Quality, Supply Chain, and Regulatory teams, gaining exposure to diverse suppliers, products, and global manufacturing operations.
What You’ll Do
- Conduct and lead risk-based audits of vendors and suppliers, focusing 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.
- Take accountability for results in an entrepreneurial environment.
- Embrace challenge and change, applying a growth mindset.
- Demonstrate a bias for action and fast decision making.
- Consistently embody company core values: Entrepreneurship, Speed, and Integrity.
- Foster collaboration across functions and contribute to a positive workplace culture.
About You
We are looking for a highly motivated Quality professional passionate about making a meaningful difference to patients’ lives through robust supplier assurance and high-quality manufacturing standards.
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.
- 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 problem‑solving with strong attention to detail.
- Experience auditing medical devices or biosimilars (desirable).
Benefits
- Global recognition program
- Employee Assistance program
- Birthday leave
- Volunteer leave (2 days)
- Remote working flexibility (up to 4 weeks)
- Compassionate leave
- Long Service Awards
Apply now, and be part of a team where your growth drives our success! Please include a CV and Cover letter.