Senior Quality Assurance Auditor – Sterile Manufacturing

*Must have external Lead Auditor qualification* Location: London (Hybrid – 2 days per week on-site, with regular international travel) 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 . 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). Why ADVANZ PHARMA? At ADVANZ PHARMA, we believe that our employees are our greatest asset. That’s why we are committed to creating an environment where every individual can thrive, contribute, and grow. Here’s what makes ADVANZ PHARMA an exceptional place to build your career: 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: We are proud to offer a comprehensive global benefits package designed to support the health, well-being, and professional growth of our employees. Our benefits include competitive compensation, health and wellness programs, opportunities for career development, and a strong focus on work-life balance: Global recognition program Employee Assistance program 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, and be part of a team where your growth drives our success* *Please include a CV and Cover letter.