Qualified Person

External Manufacturing and Supply Specialty Care (EM&S SC) is a Sanofi unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in the manufacture, testing, and transport of Sanofi products. EM&S SC staff interact with functional units within External Manufacturing Quality (SCQ), Sanofi sites, and other organizations within the External Manufacturing network (e.g. procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition intermediate (e.g. API, drug substance) and finished products with minimal risk to quality or product supply.

About the Job

Main responsibilities

In this role, you will be responsible for the release of intermediates, the EU QP certification of externally manufactured products to market and the release for export/ import of products following the fundamentals of cGMP as stipulated in Directive 2003/94/EC and other relevant regulations, applicable laws, the registration dossier and corporate requirements.

• Act as a point of contact for queries relating to QP certification and batch release and for (local) authorities and during authority inspections
• Ensure that all processes and procedures that are required for QP certification are fit for purpose and in compliance with applicable regulations
• Approval of Quality Agreements with contract manufacturers organisations, contract laboratory organisations, suppliers and vendors responsible for shipment
• Follow up on confirmed OOS results on released/distributed product and on long term stability studies that occur prior to end of shelf life and coordinating any related regulatory actions
• Support identification, assessment, control and communication of risks involving components, raw materials, finished pharmaceuticals, and medical devices within scope of responsibility
• Ensure that the deviation and change control activities are consistently and timely managed
• Ensure implementation and evaluation of corrective and preventive actions to address systemic issues
• Follow up of (potential) reportable events
• Ensure the accurate, timely, and GMP compliant management of technical product complaints from the global market manufactured by CMOs in the scope of responsibility

About you

Experience

• Minimum of 7 years of relevant work experience in the pharmaceutical and/or Biotechnology industry
• Minimum of 3 years of experience as a Qualified Person or relevant position
• Experience with all aspects of Quality related to technology transfer, validation, and routine oversight of processes and analytical methods at contract manufacturing / testing sites
• Familiarity with global GMP and ISO regulations relating to medicinal products

Soft skills

• Excellent communication and negotiation skills
• Ability to produce written and oral communications with clarity and accuracy
• Good decision-making and problem-solving skills

Education:

• Master’s degree in Pharmaceutical Sciences
• Additional basic qualification requirements can depend on local regulations and requirements of the EU member state where the individual will act as Qualified Person

Languages

• Verbal and written fluency in English

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