Senior Quality Auditor

2 weeks ago


Greater London, United Kingdom ADVANZ PHARMA Full time

Senior Quality Auditor - Pharmaceutical / Supplier Audits Be among the first 25 applicants. Date: 24 Nov 2025.Location: GB, EC4N 7BL, London (Hybrid 2 days per week on-site, with regular international travel). Company: AdvanzPharma. Job Title: Senior Specialist Quality Audits Sterile Manufacturing. About The Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for a Senior Specialist Quality Audits 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. Consistently demonstrate and embody 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. 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). Why ADVANZ PHARMA? At ADVANZ PHARMA, we believe that our employees are our greatest asset. We are committed to creating an environment where every individual can thrive, contribute, and grow. A Culture of Empowerment and Belonging We foster a workplace rooted in continuous learning, inclusivity, and collaboration. Every voice matters, and we strive to ensure our employees feel valued, respected, and empowered to make a difference. Flexibility and Support for Your Wellbeing Our agile and flexible working arrangements, paired with a comprehensive compensation and benefits package, are designed to support your health, career aspirations, and work‑life balance. Recognition That Inspires Through our Rewards and Recognition program, we celebrate the extraordinary contributions of our team members. From outstanding achievements to day‑to‑day excellence, we make appreciation a cornerstone of our culture. Global Benefits Global recognition programme Employee Assistance programme Birthday leave Two days Volunteer leave Four weeks working from anywhere Compassionate leave Long Service Award But don’t just take our word for it: 89% of employees in our Q1 2024 engagement survey would recommend ADVANZ PHARMA as a great place to work. Apply Now Please include a CV and cover letter. #J-18808-Ljbffr


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