Senior Quality Auditor - Steriles
Date: 14 Jul 2026
Location: London, United Kingdom
Company: AdvanzPharma
Job Title:
Location:
About the Role
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
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?
A Culture of Empowerment and Belonging:
Flexibility and Support for Your Wellbeing:
Recognition That Inspires:
Global Benefits:
- 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