Operational Product Quality Manager

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We are looking for an Operational Product Quality Manager to join our Montpellier facility to participate in our on-going success as a financially sound, fast-growing, socially responsible company dedicated to Global Health. As the Operational Product Quality Manager you will ensure quality standards of MedinCell raw materials and Investigational Medicinal Products (IMPs). Reporting to the Quality and Regulatory Compliance Director, you will maintain key relationships with the product development team, as well as with sub-contractors and key opinions leaders outside of the company.

Responsibilities 

Quality Strategy

  • Contribute to the development of MedinCell Quality policy and strategy, and to the implementation of best practices in the company.
  • Contribute and participate to the application and implementation of Quality standards related to the products, manufacturing (specific to IMP’s and preclinical products) and development operations.

Operational Product Quality

  • Ensure that the quality review, release and disposition of finished investigational medicinal products (subcontracted), APIs, raw Materials and components are performed according to GxP requirements.
  • Ensure compliance of raw materials (i.e. polymers, solvents, excipients), API sourcing, DP development and manufacturing operations versus cGMP requirements.
  • Ensure implementation of recall and/or complaint processes for clinical batches.
  • Ensure appropriate implementation of deviation and change control processes related to regulatory and clinical batches.
  • Participate to the building of Quality review.
  • Compile and provide Quality KPI of operational Product Quality activities.
  • Responsible for the release of Finished Investigational Medicinal Products (subcontracted), APIs, Raw Materials and Components is performed according to GxP requirements, under the supervision of the QRC Director.
  • Responsible for the implementation, communication and filing of master batch records for non-clinical studies.
  • Perform and edit CoA of products for clinical and non-clinical studies.
  • Ensure compliance of raw materials (i.e. polymers, solvents, excipients), API sourcing, DP development and manufacturing operations versus cGMP requirements.
  • Manage and evaluate deviations, CAPA and change request control related to pre-clinical, regulatory and clinical batches.
  • Contribute to the implementation of suppliers and sub-contractors complaint processes related to pre-clinical, regulatory and clinical batches.
  • Adhere to CAPA and change request/control for laboratory activities.
  • Approve the change of any reference, supplier of material and consumables before lab use.
  • Participate in the writing and approval of SOPs related to product quality; ensuring their adherence across all lab activities
  • Participate an contribute in the preparation of regulatory authorities inspections and partners audits.
  • Approve protocols, development and validation reports of analytical methods.
  • Approve protocols and reports of stability studies and specifications of drug products and raw materials.
  • Participate in quality improvement projects.
  • Identify operational quality risks and propose solutions in collaboration with other departments and teams.
  • Work closely with all the Quality members and participate if needed to the other Quality activities.

Requirements

  • Ideally PharmD or PhD in pharmaceutical sciences with industrial pharmaceutical focus.
  • Minimum 5 years of pharmaceutical experience (pharma/biopharma industry) in the Quality Assurance department.
  • Knowledge of all GxP guidance.
  • Fluency in English.
  • Experience in multicultural environments and multidisciplinary teams.
  • Experience in the development of drug product and clinical trials would be highly desirable.

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