Senior Quality Auditor - Steriles

Job Title: Senior Specialist, Auditor (Supplier / Steriles Focus) Location: London - hybrid 2 times a week on site (with travel across Europe) 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 GMP Quality Auditor . This role sits within our central Quality function and is focused on leading global supplier and CMO audits , with a strong emphasis on sterile and aseptic manufacturing environments . You will play a critical role in ensuring compliance across our external manufacturing network and supporting regulatory inspection readiness. What You’ll Do: Lead and execute GMP audits of global suppliers and CMOs , with a focus on sterile / aseptic manufacturing sites Own full audit lifecycle: planning, execution, reporting, and CAPA follow-up Support supplier qualification and onboarding , ensuring robust risk-based selection processes Provide quality oversight across the external manufacturing network , ensuring compliance with EU GMP, Annex 1, and global standards Contribute to inspection readiness activities , including preparation for MHRA, FDA, and other regulatory authorities Collaborate cross-functionally with Regulatory, Supply Chain, and Technical Operations teams 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” by working collaboratively across all business functions with open, honest, and respectful cooperation Contribute to making ADVANZ PHARMA a desired place to work About You We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients’ lives. For this role, you will also have the following: Qualifications: Degree in a relevant scientific discipline (e.g. Pharmacy, Chemistry, Life Sciences) IRCA Lead Auditor certification or equivalent (preferred) Knowledge, Skills & Experience: Significant experience in GMP Quality Assurance within the pharmaceutical industry Proven experience leading external supplier / CMO audits in a global environment Strong knowledge of sterile manufacturing, aseptic processes, and Annex 1 requirements Experience auditing fill-finish, biologics, or sterile production facilities Demonstrated ability to operate within a virtual / outsourced manufacturing model Experience managing supplier quality, technical agreements, CAPAs, and risk assessments Strong understanding of EU GMP, FDA, and ICH guidelines Excellent stakeholder management and communication skills Learning agility and scalability, with a desire to continuously improve and develop as ADVANZ PHARMA grows Ability to work collaboratively across all business functions with open, honest, and respectful cooperation 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 Annual Wellbeing Day 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 2025 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.