At a Glance
- Tasks: Lead global supplier audits and ensure compliance in sterile manufacturing environments.
- Company: ADVANZ PHARMA, a leader in specialty and rare disease medicines.
- Benefits: Flexible working, competitive pay, wellness programs, and career development opportunities.
- Other info: Join a collaborative team that values empowerment and continuous learning.
- Why this job: Make a meaningful impact on patient lives while thriving in a supportive culture.
- Qualifications: Degree in a scientific field and significant GMP Quality Assurance experience.
The predicted salary is between 65000 - 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.
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.
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
- 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!
Senior Quality Auditor - Supplier Audits - Biosimilars 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.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Quality Auditor - Supplier Audits - Biosimilars in London
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We think you need these skills to ace Senior Quality Auditor - Supplier Audits - Biosimilars in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at ADVANZ PHARMA!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show ADVANZ PHARMA that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at ADVANZ PHARMA!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At ADVANZ PHARMA, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at ADVANZ PHARMA
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at ADVANZ PHARMA that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with ADVANZ PHARMA’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
