Senior Quality Auditor - Steriles
About this role
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
Company at a glance
Partner of choice in specialty, hospital, and rare disease medicines
ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing the specialty, hospital, and rare disease medicines they depend on.
Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.
Headquartered in London, UK, we have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations.
ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.
We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.
Top Benefits
- Global recognition program
- Employee assistance program
- Birthday leave
- Annual wellbeing day leave
- Volunteer leave
- Working from anywhere
- Compassionate leave
- Long service award
- Competitive compensation
- Health and wellness programs
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