Outsourced activities Quality Manager – Qualified Person

Apply now

 
 
 

We are looking for an Outsourced Activities 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 Outsourced Activities Quality Manager reporting to the Quality and Regulatory Compliance Director, you will guarantee the respect of the Quality standards of vendors for outsourced raw materials including APIs, components and finished products regarding the manufacturing, testing and distribution Quality needs.

Responsibilities 

Quality Management Systems

  • Develop MedinCell Quality policy and strategy; implement the adherence to Quality Best Practices throughout the company
  • Implement and take part in the approval of current SOPs related to MedinCell Quality of outsourced activities.
  • Brings appropriate input on Quality management of outsourced activities to the Quality Review
  • Identify bottlenecks and proactively drive for their resolution
  • Brings appropriate input on Quality management of outsourced activities to the Quality Review

Operational Product Quality

  • Represent the Quality Team on assigned transversal project teams and contribute to the development of overall quality strategy
  • Be a subject expert on specifications of outsourced Drug Products and Raw Materials.
  • Identify the operational quality risk of outsourced vendors and propose solutions in collaboration with other departments and teams.
  • Act as a back-up to the Operational Quality Manager.

Outsourced Activities

  • Drive the outsourcing and manufacturing partnerships through KPIs
  • Manage external audits
  • Participate in vendors’ selection and lead the writing of the annual vendor audits plans
  • Review and manage quality agreements regarding outsourced activities
  • Review, approve and roll out external batch records for use of Drug Products in non-clinical studies and IMP in clinical studies.
  • Responsible for the implementation of complaints and recall processes for clinical / technical batches outsourced
  • Participates into products risk assessments when needed
  • Ensures the follow up of vendors regarding deviations, complaints and QTA

Pharmaceutical Compliance

  • Manage with the Qualified Person the Manufacturing and Importation authorization of the company when relevant.
  • Check the Manufacturing and Importation authorizations of the vendors when relevant.

Interactions

  • Participate in Quality improvement projects
  • Enhance the reputation of MedinCell with external partners, authorities and the general public.
  • Develop solid relationships with Drug Product Development teams
  • Work closely with Quality team members by embrace a collaborative work approach
  • Write reports in English for use internally or with partners
  • Participates actively to Regulatory Authorities inspections, partners / customers audits (including preparation)
  • Work closely with all the Quality members and participate if needed to the other Quality activities.

Requirements

  • Registered to the national board of Pharmacists
  • Qualified as a QP
  • Minimum 5 years of pharmaceutical experience (pharma/biopharma industry) in the Quality Assurance department
  • Experience in outsourced activities, and in Quality audits
  • Knowledge of all GxP guidance
  • Experience in pharmaceutical manufacture and testing
  • Comfortable reading and writing regulatory documents in English
  • Experience in multicultural environments and multidisciplinary teams
  • Experience in the development of drug product and clinical trials would be highly desirable
  • Strong team spirit and open sharing of all the information necessary to successfully achieve overall work goals

Apply now

CONTACT

  • This field is for validation purposes and should be left unchanged.