At a Glance
- Tasks: Lead supplier quality audits and ensure compliance across our biosimilars supply chain.
- Company: ADVANZ PHARMA, a leader in specialty and rare disease medicines.
- Benefits: Competitive salary, flexible working, health programs, and career development opportunities.
- Other info: Join a culture of empowerment, inclusivity, and continuous learning.
- Why this job: Make a real impact on patient lives while working in a dynamic environment.
- Qualifications: Degree in a scientific discipline and experience in pharmaceutical quality auditing.
The predicted salary is between 50000 - 55000 £ per year.
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 Specialist, Quality Audits (Biosimilars). This role will play a key part in supporting our growing biosimilars portfolio by leading supplier quality audits and providing expert oversight across our global external manufacturing network. Working closely with suppliers, CMOs, laboratories and cross-functional stakeholders, you will help ensure compliance, inspection readiness and continued quality excellence across our supply chain.
What You’ll Do:
- Lead and execute risk-based GMP/GDP audits of CMOs, API manufacturers, laboratories, distributors, service providers and other critical suppliers.
- Support supplier qualification, requalification and ongoing supplier assurance activities across the global supply chain.
- Evaluate supplier quality systems, audit observations, CAPA effectiveness and compliance risks using a risk-based approach.
- Support inspection readiness activities and provide supplier quality expertise during audits and regulatory inspections.
- Apply knowledge of biologics and biosimilars throughout supplier audit planning, quality risk assessment and lifecycle management activities.
- Collaborate with Supply Chain, Regulatory Affairs, Technical Operations, New Product Introduction and Quality teams to maintain compliant outsourced operations.
- Thrive in an entrepreneurial environment, and take accountability for results.
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 Pharmacy, Chemistry, Microbiology, Pharmaceutical Sciences, Life Sciences or a related scientific discipline.
- Formal auditing qualification, auditor training, or demonstrated competency in conducting GxP audits.
- Lead Auditor qualification or advanced audit training (advantageous).
Knowledge, Skills & Experience:
- Extensive pharmaceutical quality auditing experience.
- Experience auditing biologics and/or biosimilar suppliers and manufacturing partners.
- Strong understanding of biologics and biosimilars manufacturing processes, supplier quality systems and associated regulatory expectations.
- Experience supporting supplier qualification, supplier oversight and inspection readiness activities.
- Demonstrated ability to assess supplier quality risks, CAPA effectiveness and compliance gaps using a risk-based approach.
- Good working knowledge of GMP/GDP regulations and quality risk management principles.
- Willingness to undertake regular international travel for supplier audits and quality oversight activities.
- A positive and ‘can-do’ approach, biased towards finding solutions and embracing change.
- Inspired by our values of entrepreneurship, speed and integrity.
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.
Quality Auditor - Supplier Audits - Biosimilars 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 Quality Auditor - Supplier Audits - Biosimilars
✨Unlock Networking Opportunities
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We think you need these skills to ace Quality Auditor - Supplier Audits - Biosimilars
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!
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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.
