Quality Assurance Operations Manager

About the role

We are seeking an enthusiastic Quality Assurance Operations Manager to lead quality oversight of third‑party contract manufacturing organisations, API suppliers and service providers, ensuring compliance with regulatory requirements.

Key responsibilities

• Plan and execute quality audits at suppliers and CDMOs, and drive implementation of CAPA plans.
• Negotiate and manage Quality Agreements with external partners.
• Support suppliers in regulatory inspection preparation and provide GMP training and coaching.
• Review and approve quality documentation for development projects and technology transfers, including specifications, batch records, validation protocols, risk assessments and change controls.
• Oversee QA activities related to CDMO/service provider operations to ensure GMP and GDP compliance, and recommend continuous improvements.

Required profile

• University degree in pharmacy, chemistry or a related scientific discipline.
• Minimum 8 years of experience in pharmaceutical production or control, with strong knowledge of EU‑GMP, GDP and other international GMP standards.
• Hands‑on experience with regulatory inspections (EMA, FDA, ANVISA, etc.) and with oral dosage forms and injectables.
• Proven audit experience and ability to negotiate quality agreements.

Required skills

• EU‑GMP and GDP compliance.
• Regulatory inspection readiness (EMA, FDA, ANVISA, Russia).
• Audit planning and execution.
• Quality documentation review and approval.
• Risk assessment and CAPA management.

What we offer

• Exciting challenges with daily learning opportunities.
• Supportive, collaborative environment where ideas are valued.
• Career development through ongoing training and development programmes.
• Competitive compensation and employee rewards recognising hard work.
• Inclusive and fun culture celebrating team successes.