Senior Quality Assurance Specialist (Pharmaceutical GDP/GMP)

We are seeking an experienced Senior Quality Assurance Specialist to join an international pharmaceutical organisation based in Luxembourg.

In this role, you will contribute to the oversight, maintenance and continuous improvement of the company's pharmaceutical Quality Management System (QMS), ensuring compliance with EU Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) requirements.

The position offers broad exposure to international pharmaceutical operations, including product licensing, contract manufacturing, distribution and quality governance.

You will collaborate closely with internal departments, international affiliates, manufacturers, suppliers, customers and external service providers to maintain regulatory compliance and promote a strong quality culture.

Responsibilities

• Act as the designated Responsible Person for GDP for one Luxembourg entity and Deputy/Backup Responsible Person for another, in accordance with applicable regulatory authorisations.

• Collaborate with existing Responsible Persons to ensure consistent GDP governance, regulatory compliance and operational oversight.

• Maintain and continuously improve the local Quality Management System, including documentation, training, quality events, CAPA, change control and quality performance indicators.

• Ensure inspection readiness and support regulatory inspections and internal and external audits.

• Serve as the primary Quality Assurance contact for internal departments, affiliates, suppliers, manufacturers, customers and service providers.

• Coordinate quality-related projects, applying risk-based approaches to strengthen compliance and operational efficiency.

• Manage product quality complaints, deviations, investigations and corrective and preventive actions.

• Prepare, review and maintain pharmaceutical quality agreements, technical agreements and quality-related contractual documentation.

• Review commercial agreements to ensure alignment with regulatory requirements and internal quality standards.

• Support supplier qualification, oversight activities and ongoing quality monitoring.

• Monitor compliance with EU GDP and GMP regulations, corporate quality requirements and internal procedures.

• Maintain accurate quality records, databases and documentation to support traceability and regulatory compliance.

• Provide day-to-day Quality Assurance guidance to operational teams and business stakeholders.

• Identify and implement continuous improvement initiatives across pharmaceutical quality processes.

Requirements

• Formal qualification as a pharmacist issued by an EU Member State, eligible for professional recognition in Luxembourg under Directive 2005/36/EC, Annex V, point 5.6.2.

• 8-15 years of experience in pharmaceutical Quality Assurance, gained within established pharmaceutical organisations operating under EU GDP and/or EU GMP regulations for medicinal products for human use.

• Strong knowledge of EU pharmaceutical regulatory requirements, particularly Good Distribution Practice and Good Manufacturing Practice.

• Proven experience developing, reviewing and managing pharmaceutical quality agreements, technical agreements and quality-related contractual provisions.

• Comprehensive understanding of pharmaceutical Quality Management Systems, including documentation management, deviations, CAPA, change control, training and quality metrics.

• Experience supporting audits, regulatory inspections, supplier oversight and customer quality management.

• Ability to interpret regulatory requirements and translate them into practical, compliant and risk-based operational solutions.

• Strong analytical, organisational and problem-solving capabilities.

• Excellent communication skills, with the ability to explain complex regulatory and quality matters to technical and non-technical stakeholders.

• Proactive, self-motivated and solution-oriented approach, with a strong sense of ownership and accountability.

• Ability to work effectively across departments, cultures and seniority levels.

• Excellent planning, prioritisation and time-management skills.

• Strong customer orientation and commitment to pharmaceutical quality and regulatory compliance.

• Excellent English proficiency, both written and spoken.

• French at minimum B2 level.

• Working proficiency in German is an advantage.

Benefits

• Permanent employment contract within an international pharmaceutical environment.

• Hybrid working arrangements depending on location and operational requirements.

• Comprehensive corporate health insurance benefits.

• Meal vouchers.

• Potential accommodation support for up to six months during the probationary period.

• Exposure to international pharmaceutical licensing, contract manufacturing and distribution activities.

• Opportunity to take responsibility for GDP governance and contribute directly to regulatory compliance.

• Active involvement in developing and continuously improving pharmaceutical Quality Management Systems.

• Cross-functional collaboration with international pharmaceutical teams and external stakeholders.

• Professional development opportunities within a quality-driven, regulated industry.