Qse jobs in France

International SOS Supply is dedicated to saving lives and contributing to the overall improvement of health in the remotest corners of the world. Be that on land, air, or water. We achieve this by providing the right medical supplies precisely when and where they are needed.

The Director of Quality and Deputy Responsible Pharmacist is responsible for ensuring full compliance with French regulations, including Good Manufacturing Practices (GMP / BPF) and Good Distribution Practices (GDP / BPDG), as stipulated in Article R5124-36 of the French Public Health Code.

This role is pivotal in maintaining the highest standards of quality and compliance across the entire supply chain, including the storage, manufacturing, distribution, and import / export of pharmaceuticals, medical devices, consumables and medical kits.

As a key member of the leadership team, the Director of Quality will also collaborate closely with internal stakeholders, customers, regulatory bodies, industry associations and external suppliers to ensure the ongoing success of the organization’s quality initiatives.

The site is a pharmaceutical site (GMP / GDP) of 20 people manufacturing medical kits to assistance, airlines and maritime companies.

• Serve as the Designated Representative / Responsible Person, ensuring compliance with national and international regulations for the sourcing, receipt, storage, and distribution of pharmaceuticals and medical supplies.
• Maintain ISO 9001 Certification and drive continuous compliance, with the goal of achieving ISO 13485 certification.
• Oversee compliance with GMP / BPF and GDP / BPDG standards, ensuring that pharmaceuticals (including controlled substances), medical devices, and consumables are stored, distributed, and managed in accordance with regulations.
• Liaise with regulatory licensing and certification authorities to ensure all licenses and certifications are valid and up to date.
• Manage regulatory inspections, license applications, product registrations, and respond to regulatory queries or observations in a compliant and timely manner.

• Develop, implement, and continuously improve the Quality Management System (QMS),at site to meet local, corporate and ISO standards.
• Implement TrackWise Digital Quality Management System at Site for Quality Management.
• Ensure adherence to Good Documentation Practices (GDP) and Data Integrity Principles for all quality documentation, including training materials, quality records, and operational documentation.
• Manage the safety and quality assurance program (PSAQ), ensuring that all suppliers are approved in compliance with corporate supply chain policies.

• Conduct periodic self-inspections and internal audits to ensure adherence to QMS and compliance with industry regulations.
• Analyze quality management systems data (e.g., internal audits, non-conformances, complaints, deviations) and prepare trend analyses for management review meetings (MRM).
• Investigate root causes of deviations, non-conformances, and complaints, and implement appropriate corrective and preventive actions (CAPAs).
• Lead and support quality and compliance projects related to International SOS Supply’s initiatives in France.

• Performs qualification of pharmaceuticals, medical devices suppliers and procured products following applicable procedures and ensure the establishment of quality agreements with suppliers.
• Oversee product recalls and returns, ensuring they are managed in compliance with applicable regulations and SOPs.
• Manage relationships with key suppliers and customers to maintain a compliant, efficient, and high-quality supply chain.

• Identify training needs for site personnel and provide training on new procedures and quality standards.
• Ensure that the workforce is well-equipped to maintain compliance and uphold quality standards in their daily operations.

• Work closely with the Quality Managers, MedAire, the Global Director of Quality and Sustainability, the Supply Division, and legal teams to align quality and compliance initiatives.
• Provide regular quality status updates to the management team and relevant stakeholders, ensuring timely and accurate reporting.

• Pharmacist / Doctor of Pharmacy ( registrable in sections B and C ), with the required experience to manage a pharmaceutical establishment as outlined in Article R5124-2, paragraph 14 of the Public Health Code.
• In-depth knowledge of Good Manufacturing and Distribution Practices, ISO 9001, and ISO 13485 standards.
• Comprehensive understanding of national, international, and GDP guidelines for the sourcing, receipt, storage, and distribution of pharmaceuticals and medical devices.
• Hands-on experience in a quality management role, ideally within healthcare, logistics, or a related industry.
• Good verbal and written English communication skills, with the ability to engage effectively with internal teams, customers, and regulatory bodies.
• A proactive and dynamic approach, with the ability to lead projects, implement solutions, and improve processes.
• ISO 9001 and / or ISO 13485 Lead Auditor Certification / experience will be a plus.

Salary : 80 000€ - 90 000€ + Bonus