Specialist, Quality Audits - Biosimilars

Location: London, United Kingdom (Hybrid)

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) .

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
• Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity..

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.

Global Benefits:

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
• Compassionate leave
• 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.

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