Senior Quality Auditor - Pharmaceutical / Supplier Audits

Advanz Pharma; United Kingdom; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading pharmaceutical company in the UK seeks a Senior Specialist in Quality Audits. This role involves conducting audits of sterile manufacturing facilities, ensuring compliance with EU regulations, and collaborating with diverse teams. The ideal candidate will hold a relevant degree and auditing qualifications, with a strong background in quality assurance. Competitive compensation and hybrid working options are offered.

Benefits

Global recognition program

Employee Assistance program

Birthday leave

Two days Volunteer leave

Four weeks working from anywhere

Qualifications

• Degree in Chemistry, Pharmacy, Microbiology, or equivalent.
• General auditing qualification (essential).
• External Lead Auditor qualification (essential).

Responsibilities

• Conduct and lead risk-based audits of vendors and suppliers.
• Monitor and maintain the vendor audit program.
• Perform risk-based assessments of audit outcomes.

Skills

Quality Audit Experience

Communication Skills

Organizational Skills

Education

Degree in Chemistry, Pharmacy, Microbiology or equivalent

General auditing qualification

External Lead Auditor qualification

Job description

Job Title: Senior Specialist - Quality Audits - Sterile Manufacturing

Location: London(Hybrid - 2 days per week on-site, with regular international 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.
• General auditing qualification (essential).
• External Lead Auditor qualification (essential).

Knowledge, Skills & Experience

• Working experience in a similar Quality Audit role within the pharmaceutical industry.
• Essential: Proven experience auditing sterile manufacturing facilities.
• 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.

Global Benefits

• Global recognition program
• Employee Assistance program
• Birthday leave
• Two days Volunteer leave
• Four weeks working from anywhere
• Compassionate leave
• Long Service Award

But don't just take our word for it: 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.