Quality Assurance Senior Specialist

About the role

As a member of the Luxembourg Quality Assurance team within Menarini Group, you will oversee and continuously improve the company’s pharmaceutical Quality Management System. The role provides broad exposure to worldwide licensing, contract manufacturing and distribution activities in a GDP and GMP‑regulated environment.

Key responsibilities

• Act as Responsible Person for GDP for one Luxembourg entity and Deputy/Back‑up Responsible Person for another, ensuring consistent governance across entities.
• Maintain and improve the local QMS, including documentation management, training, quality events, CAPA, change control, metrics and inspection‑readiness.
• Serve as the QA reference point for internal and external stakeholders such as affiliates, suppliers, customers and manufacturers.
• Support and coordinate quality projects using a risk‑based, pragmatic approach to drive compliance and operational efficiency.
• Manage product quality complaints, deviations, investigations and follow‑up actions, ensuring proper documentation and record keeping.
• Draft, review and maintain quality and technical agreements, clarifying roles, responsibilities and quality expectations.
• Participate in GMP and GDP audits, supplier oversight and inspection‑preparation activities as needed.

Required profile

• Significant experience in pharmaceutical quality assurance, preferably in GMP/GDP environments.
• Strong knowledge of Quality Management Systems, CAPA, change control and audit processes.
• Proven ability to work with cross‑functional teams, affiliates and external partners.
• Excellent analytical and problem‑solving skills with a focus on continuous improvement.
• Fluency in English; knowledge of French or German is a plus.

Required skills

• In‑depth understanding of GMP and GDP regulations.
• Experience with QMS documentation, training, and metrics.
• Capability to lead CAPA and change‑control activities.
• Audit and inspection readiness expertise.
• Risk‑based approach to quality project management.