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For Companies At a Glance
- Tasks: Lead risk-based audits of suppliers, ensuring compliance with global manufacturing standards.
- Company: Join ADVANZ PHARMA, a leader in specialty and rare disease medicines.
- Benefits: Enjoy flexible working, competitive pay, and a supportive culture focused on your growth.
- Why this job: Make a real impact on patient lives through high-quality manufacturing and supplier assurance.
- Qualifications: Degree in Chemistry, Pharmacy, or Microbiology; experience in Quality Audit roles required.
- Other info: Be part of a collaborative team that values empowerment and continuous learning.
The predicted salary is between 48000 - 72000 £ per year.
Location: London (Hybrid – 2 days per week on-site, with regular European travel)
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 Specialist – Quality Audits. In this role, you will support the lifecycle management of our global vendor and supplier network, ensuring compliance with EU GMP, EU GDP, and other applicable regulatory standards. You will lead risk-based audits—primarily of sterile manufacturing facilities—while mentoring team members and deputising for the Senior Quality Manager – Supplier Assurance as required. This is a highly collaborative role, working closely with colleagues across Quality, Supply Chain, and Regulatory teams, and offers exceptional exposure to diverse suppliers, products, and global manufacturing operations.
What You’ll Do
- Conduct and lead risk-based audits of vendors and suppliers, with a strong focus on sterile manufacturing sites.
- Monitor and maintain the vendor audit programme, ensuring compliance with EU GMP, EU GDP, and relevant MA requirements.
- Perform risk-based assessments of audit outcomes and liaise with QPs and senior management on required actions.
- Monitor and maintain internal and external CAPAs.
- Maintain vendor validity within the SAP ERP system.
- Evaluate and interpret global regulations to support audit activities.
- Create, revise, and review QA audit documentation, including checklists, questionnaires, SOPs, and guidance documents.
- Mentor team members and support capability development across the audit function.
- Deputise for the Audit Manager as required.
- 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.
- Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity.
- Drive the spirit of “One Team” through open, honest, and respectful collaboration across functions.
- Contribute to making ADVANZ PHARMA a desired place to work.
About You
We are looking for a highly motivated Quality professional who is passionate about making a meaningful difference to patients’ lives through robust supplier assurance and high-quality manufacturing standards.
Qualifications
- Degree in Chemistry, Pharmacy, Microbiology, or equivalent.
Knowledge, Skills & Experience
- Working experience in a similar Quality Audit role within the pharmaceutical industry.
- Experience auditing external suppliers such as labs, distributors, and transport partners.
- Strong understanding of EU GMP, EU GDP, and relevant global regulations.
- Experience with CAPA management and risk-based decision making.
- Ability to travel nationally and internationally at least twice per month.
- Strong organisational, time-management, and multitasking skills.
- Excellent written and verbal communication skills, including interacting with senior stakeholders at third-party suppliers.
- Proven ability to work independently, remain calm under pressure, and manage competing priorities.
- Logical, methodical approach to problem-solving with strong attention to detail.
- Experience auditing medical devices or biosimilars (desirable).
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
- Two days Volunteer leave
- Four weeks working from anywhere
- Long Service Award
89% of employees in our Q1 2024 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!
Please include a CV and Cover letter.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Accounting/Auditing and Quality Assurance
Industries: Pharmaceutical Manufacturing and Hospitals and Health Care
Senior Specialist QA Supplier Auditor – Sterile Manufacturing in England employer: ADVANZ PHARMA
Contact Detail:
ADVANZ PHARMA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Specialist QA Supplier Auditor – Sterile Manufacturing in England
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in quality assurance. A friendly chat can lead to insider info about job openings or even referrals that could boost your chances.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU GMP and EU GDP regulations. Be ready to discuss how you've applied these in past roles, especially during supplier audits. Show them you’re not just a fit on paper but also in practice!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in joining ADVANZ PHARMA and being part of our amazing team.
We think you need these skills to ace Senior Specialist QA Supplier Auditor – Sterile Manufacturing in England
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in quality audits, especially in sterile manufacturing. We want to see how your skills align with the role, so don’t be shy about showcasing your achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality assurance and how you can contribute to our mission at ADVANZ PHARMA. Keep it engaging and personal.
Showcase Your Audit Experience: Since on-site supplier audits are a must, make sure to detail your auditing experience clearly. We love seeing specific examples of how you've led audits and managed compliance with EU GMP and GDP standards.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity. Don’t miss out!
How to prepare for a job interview at ADVANZ PHARMA
✨Know Your Auditing Stuff
Make sure you brush up on your knowledge of EU GMP and EU GDP regulations. Be ready to discuss how you've applied these in past audits, especially in sterile manufacturing environments. This will show that you’re not just familiar with the theory but have practical experience too.
✨Showcase Your Mentoring Skills
Since this role involves mentoring team members, think of examples where you've successfully guided others. Prepare to share how you’ve helped colleagues develop their skills or overcome challenges in quality assurance. This will highlight your leadership potential.
✨Prepare for Risk-Based Discussions
Expect questions about risk-based assessments and CAPA management. Have specific examples ready that demonstrate your decision-making process and how you’ve handled audit outcomes. This will illustrate your analytical skills and ability to manage compliance effectively.
✨Emphasise Collaboration
This role requires working closely with various teams, so be prepared to discuss how you’ve collaborated in the past. Share stories that reflect your ability to communicate openly and work as part of a team, aligning with ADVANZ PHARMA's core values of 'One Team' spirit.
