At a Glance
- Tasks: Lead global GMP audits and ensure compliance in sterile manufacturing environments.
- Company: Join ADVANZ PHARMA, a leader in specialty and rare disease medicines.
- Benefits: Enjoy flexible working, wellbeing days, and a global recognition programme.
- Other info: Collaborative culture with excellent career growth opportunities.
- Why this job: Make a real impact on patient lives while thriving in a dynamic environment.
- Qualifications: Degree in a scientific field and experience in GMP Quality Assurance required.
The predicted salary is between 60000 - 80000 £ per year.
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.
Responsibilities
- 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.
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
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
Senior Quality Auditor - Steriles in London employer: ADVANZ PHARMA
ADVANZ PHARMA is an exceptional employer, offering a dynamic work environment in Scotland where employees are empowered to make a meaningful impact on patient lives through innovative healthcare solutions. With a strong focus on professional development and a culture that values integrity, speed, and entrepreneurship, team members enjoy opportunities for growth while collaborating with diverse stakeholders in the healthcare sector. The company's commitment to excellence and its global presence provide unique advantages for those looking to advance their careers in the pharmaceutical industry.
