Quality and Compliance GMP Auditor

About the role

As a Quality and Compliance GMP Auditor you will lead Quallent Pharmaceuticals’ risk‑based supplier audit programme, performing GMP audits of CMOs, CROs and other vendors to ensure regulatory and quality compliance.

Key responsibilities

• Plan and conduct risk‑based GMP audits of contracted suppliers, reviewing pre‑audit documentation and coordinating on‑site or remote audit activities.
• Prepare detailed audit reports documenting findings, risks and recommendations, and follow up on corrective actions.
• Evaluate manufacturing processes, quality systems, validation activities, product testing and supporting documentation for GMP compliance.
• Assess supplier Quality Management Systems, including change control, deviation management, CAPA and document control.
• Identify compliance gaps, develop remediation plans with internal teams and suppliers, and support Quallent’s Quality Oversight Program.

Required profile

• Bachelor’s degree in Pharmacy, Chemistry, Biology or a related scientific discipline.
• 2–5 years of experience in pharmaceutical, biotechnology or medical device quality functions, with at least 4 years in compliance and quality systems management.
• Proven experience conducting GMP audits of oral solid dosage and sterile manufacturing facilities; exposure to biologics or biosimilars is a plus.
• Strong knowledge of cGMP, FDA regulations and industry guidance.

Required skills

• GMP audit methodology (on‑site and remote).
• cGMP and FDA regulatory knowledge.
• Risk assessment and gap analysis.
• Audit reporting and corrective‑action tracking.
• Evaluation of Quality Management Systems, CAPA, change control and deviation management.

What we offer

• Salary range USD 90,000 – 145,000 per year.
• Highly competitive benefits package.