Senior Quality Auditor - Steriles

Advanz Pharma

London, United Kingdom

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