Denain Greenfield Project Qualified Person and Quality Director

In order to support its ambitious greenfield project to build a dedicated plant for the production of chondroitin sulfate at nutraceutical and pharmaceutical grades in Denain, the Gnosis by Lesaffre Business Unit is recruiting an experienced Quality professional to act both as Qualified Person for the plant throughout its construction and exploitation, and temporarily as QA Manager for broader quality topics related to the interactions of the business unit with Lesaffre plants outside its direct scope of authority.

Based in Marcq-en-Baroeul, reporting directly to the Operations Director (in Italy) and in close cooperation with relevant local colleagues, the QP / Quality Manager will be in charge of the following missions.

As Qualified Person

During the construction phase:

·         Defines and oversees the successful execution of the future plant’s Validation Master Plan (VMP)

·         Defines, hires, trains and manages the required Quality organization for the future plant

·         Leads all necessary interactions with French and other national Health Authorities to successfully register the future plant for production and release of chondroitin sulfate to established pharmaceutical standards

·         Oversees the DMF (authorization dossier) to be submitted by the company as API manufacturer and any other requests related to the pharmaceutical activities

·         It is responsible of the HA inspection for the new plant authorization

During the exploitation phase:

·         It is responsible of the Batch review and product release for the Market

·         It is responsible for the compliance to the cGMP and the quality rules of the manufacture, batch follow-up (including the management of complaints, batch recalls, etc.), distribution (including transport conditions), importation and exportation of the products manufactured in the Denain plant, as well as the corresponding storage operations and labelling operations

·         Oversees and signs the DMF (authorization dossier) submitted by the company as API manufacturer and any other requests related to the pharmaceutical activities

As QA Manager

• Supervises and supports the Quality team, managing priorities, eliminating bottlenecks and addressing critical issues;
• Coordinates and supports the Quality Assurance (quality system activities ie change, deviations, complaint, Batch review, etc), Quality Control, and Validation activities related to Lesaffre plants outside the business unit, participates in the definition of roles, responsibilities, KPIs and performance evaluation, provides direction and support on critical issues and non-conformities;
• Defines and proposes to the Top management mid and long-term Quality strategy, defining procedures and site standards according to cGMP and other certifications in place;
• Supervises the consolidation of non-conformities, guaranteeing correct communication with departments and the development and execution of appropriate corrective actions;
• Represents the department in strategic meetings to define future plan and manage critical issues;
• Opens or proposes the opening of new departmental or interdepartmental projects to improve quality processes and procedures;
• Guarantees support to the R&D and Plant Director and Department’s Managers in setting quality control standards and managing a smooth industrialization process;
• Fosters the quality system continuous improvement by ensuring knowledge sharing on troubleshooting and corrective actions within the Site
• Coordinates evaluations regarding product quality aspects, reviews quality unit performance and implements necessary corrective actions, sharing the assessment with the company Direction
• Ensures the execution of risk management coordinating risk evaluations on activities that deviate from specifications