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Valneva

Develops, manufactures, and markets infectious-disease vaccines

Deputy Responsible Pharmacist and Quality Assurance Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeLyon, France

About the Job

Requirements

  • Be a graduate pharmacist.
  • Have at least 3 years of experience in a pharmaceutical Exploitant.
  • Have experience compliant with articles R.5124-16 and R.5121-164 of the French Health Code.
  • Be registered or registrable at section B of the College of Pharmacists as Pharmacien Responsable Intérimaire Exploitant.
  • Have a master's degree in regulatory or quality affairs, ideally.
  • Be fluent in spoken and written English.
  • Have solid knowledge of GxP and Exploitant regulations.
  • Demonstrate the ability to make decisions in stressful situations.
  • Understand potential public health issues related to the activity.
  • Demonstrate independence, objectivity, ethics, and confidentiality.

Responsibilities

  • Take part in implementing, maintaining, and improving the VALNEVA France SAS Quality Management System in line with group quality policies, GMP/GDP/GVP guidelines, and the Public Health Code.
  • Participate in the affiliate personnel training program.
  • Contribute to continuous improvement of the Exploitant through risk analysis.
  • Manage deviations, corrective and preventive actions, and change control.
  • Manage Product Technical Complaints.
  • Participate in self-inspections and internal and external audits.
  • Manage supplier qualification and monitoring.
  • Assist the Pharmacien Responsable with product recalls and potential counterfeit-product cases.
  • Approve returns to saleable stock when needed.
  • Participate in inspection readiness, Management Review, and Quality Risk Management.
  • Review Product Quality Reviews.
  • Manage the marketing authorization lifecycle of marketed products.
  • Review product packaging materials intended for the territory.
  • Perform regulatory intelligence.
  • Assist the Pharmacien Responsable in managing out-of-stock situations.
  • Set up MITM analysis and PGP, if applicable.
  • Monitor shortage situations.
  • Assume pharmaceutical responsibility during the planned or unplanned absence of the Pharmacien Responsable.
  • Promote the Exploitant regulatory approach with internal and external stakeholders and control its implementation.
  • Develop trusting professional relationships with governmental authorities.

Desired Qualifications

  • A master's degree in regulatory or quality affairs is ideally desired.

About the Company

Valneva

Develops, manufactures, and markets infectious-disease vaccines

Valneva develops, manufactures, and sells specialty vaccines to prevent infectious diseases with high unmet medical needs, including Lyme disease, COVID-19, and chikungunya, plus travel health vaccines. Its vaccines work by training the immune system to recognize and fight specific pathogens, supporting public health through preventive immunization. It differentiates itself through a focused, niche vaccine portfolio, active involvement in travel health and clinician education, and partnerships with governments and international organizations, along with ESG commitments. Its goal is to improve access to safe vaccines and protect public health by addressing critical health needs worldwide.

Company size
501-1,000
Company stage
IPO
Headquarters
Saint-Herblain, France
Founded
1999

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