Quality Assurance Senior Specialist

As part of the Luxembourg Quality Assurance team, within a Luxembourg-based affiliate of the Menarini Group, a leading international pharmaceutical company, the Candidate will contribute to the effective oversight, maintenance and continuous improvement of the company’s pharmaceutical Quality Management System. This role offers broad exposure to activities related to worldwide licensing, contract manufacturing and distribution of medicinal and non-medicinal products, in a GDP and GMP-regulated environment. The Candidate will work closely with internal departments, affiliates, manufacturers, suppliers, customers, service providers and corporate quality functions. The Candidate will support GDP governance, Quality Management System (QMS) performance, inspection readiness and continuous improvement initiatives, while helping to promote a strong quality culture across the organisation. Main

responsibilities:
• Act as Responsible Person for GDP for one Luxembourg entity and as Deputy / Back-up Responsible Person for GDP for another Luxembourg entity, in accordance with formal appointments, delegated responsibilities and the applicable distribution authorisations.
• Perform these responsibilities in close cooperation with, and under the coordination of, the existing Responsible Person / Deputy Responsible Person, to ensure a consistent, harmonised and effectively supervised approach to GDP governance across the Luxembourg entities.
• Contribute to maintaining effective GDP oversight, including continuity of Responsible Person duties, appropriate back-up and timely escalation of quality or compliance matters.
• Manage and execute activities related to the governance, maintenance and continuous improvement of the local QMS, including documentation management, training, quality events, CAPA, change control, quality metrics and inspection-readiness activities, in alignment with applicable regulations, Group standards and local procedures.
• Act as a QA reference point for internal and external stakeholders, including affiliates, third parties, suppliers, customers, service providers and manufacturers.
• Support and coordinate quality projects, applying a risk-based and pragmatic approach to ensure compliance, operational efficiency and continuous improvement.
• Manage and support quality processes related to product quality complaints, deviations, investigations and related follow-up actions, ensuring appropriate documentation and maintenance of quality records and databases.
• Draft, review and maintain quality and technical agreements with internal and external stakeholders, ensuring that roles, responsibilities and quality expectations are clearly defined.
• Review quality-related provisions of commercial agreements to ensure alignment with company quality standards and applicable regulatory requirements.
• Participate, as applicable, in GMP and GDP audits, supplier oversight activities and inspection-preparation activities, according to experience and operational needs.
• Provide day-to-day QA support to the business and contribute to ensuring that activities are performed in accordance with company procedures, Group requirements and applicable regulations. Qualifications and

experience:
Mandatory requirements
• Formal qualification as a pharmacist issued by an EU Member State and eligible for recognition in Luxembourg under the applicable EU framework for the recognition of professional qualifications, including Directive 2005/36/EC, Annex V, point 5.6.2.
• 8 to 15 years of experience in Quality Assurance within recognized pharmaceutical companies, in a EU GDP and/or EU GMP-regulated environment related to medicinal products for human use.
• Excellent command of English, both written and spoken, with the ability to operate professionally in English, express complex reasoning clearly, and communicate quality, regulatory and operational matters with precision to both technical and non-technical stakeholders.
• Professional proficiency (minimum B2 level) in French and/or German, as necessary to meet the requirements to get the authorisation to practise as a pharmacist in Luxembourg. Other requirements
• Proven experience in drafting, reviewing and managing pharmaceutical quality agreements, technical agreements and quality-related provisions of commercial agreements.
• Solid understanding of pharmaceutical QMS, including documentation management, product quality complaints, deviations, CAPA, change control, training, audits, quality metrics and supplier/customer oversight.
• Ability to interpret regulatory and corporate quality requirements and translate them into practical, compliant and risk-based operational solutions. Personal Skills & Competencies:
• Proactive, self-motivated, and solution-oriented, with a strong sense of ownership.
• Collaborative team player, able to work effectively across functions, cultures, and seniority levels.
• Strong communication skills, with the ability to convey quality requirements clearly to diverse stakeholders.
• Well-organized, with excellent planning, prioritization, and time-management skills.
• Customer-focused, with a strong commitment to quality and regulatory compliance.

We offer
• A permanent contract within an international pharmaceutical Group.
• Broad exposure to GDP and GMP-regulated activities, including licensing, contract manufacturing, distribution and international stakeholder management.
• The opportunity to play an active role in the continuous improvement of the local Quality Management System.
• A cross-functional position within a collaborative and quality-driven environment. THE COMPANY Menarini Group is the leading Italian pharmaceutical company with a global presence, recognized worldwide for the quality of its products and services. Its success is built on a long-term strategy focused on Research, Innovation, and Internationalization, combined with a deep commitment to understanding and meeting the evolving needs of physicians and patients. The Group is dedicated to delivering high-quality therapeutic and diagnostic solutions, guided by strong ethical principles, a continuous drive for innovation, a people-centric approach, and a steadfast commitment to environmental sustainability. Collaboration with international partners is one of Menarini Group’s key strengths. By fostering strategic partnerships, the Group creates synergies that drive the development of innovative healthcare solutions, pharmaceutical products, and value-added services. At Menarini, quality is more than a standard—it is the foundation of a shared strategy that guides every aspect of the Group’s operations and supports its mission to improve patients’ lives worldwide.