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Site Quality Support Manager

Sanofi-Aventis

Frankfurt, Germany

Works with the GMQO Injectables Platform Operational Quality Head and the Site Quality Managers to ensure that, for the sites within his/her perimeter in the Injectables platform, the requirements of Sanofi’s Quality System are correctly implemented and that the sites are producing products that are of correct quality and compliant to regulatory requirements.

Key Contributions & Activities:

  • Reviewing the effectiveness of the sites’ Quality Systems, Quality program and inspection readiness though the annual site Quality Review, review of sites’ Quality and Compliance KPIs and through routine contact with the sites on Quality matters;
  • Ensuring appropriate communication with the site and GMQO Management through site visits or appropriate alternative contacts (example: teleconference or web meeting), with systematic provision of either visit reports or meeting minutes to record items agreed and actions planned;
  • Providing a consolidated monthly report on sites’ Quality activities and performance;
  • Ensuring that the sites’ Quality units are adequately trained in Sanofi Quality System and Regulatory requirements and providing/organising if needed appropriate training on site;
  • Integrating risk management principles into Quality systems;
  • Reviewing, validating and tracking of risks entered in the Phenix Risk module by the sites, with regular update through investigation reports;
  • Establishing and leading Quality ad-hoc boards for each Rapid Quality Notification raised by the sites to ensure and support timely actions, escalation (if needed) and closure of the issue raised;
  • Keeping the sites informed on regulatory and Sanofi expectations concerning Quality and Compliance;
  • Organizing Quality networks to assist in sharing of information, identification of best practices and actions on continuous improvement;
  • Promoting performance and innovation initiatives;
  • Leading specific Quality topics, as agreed with the GMQO Operational Quality Head, that impact across GMQO/IA operations;
  • Review and approve site Quality Operations organization and key quality positions.

Supports:

  • Development of the sites’ annual Quality program, ensuring full alignment with the GMQO Roadmap priorities/actions and with the site specific objectives;
  • Review of the sites’ Quality organization effectiveness, resources and needs, ensuring it is properly staffed/resourced and can act independently on quality issues;
  • Preparation and review of the Risk Management Report;
  • GMP aspects of Regulatory activities (example product changes, site projects, product transfers) including by attendance and input to Corporate Change Control and other meetings as necessary;
  • External inspection and internal audit readiness through assistance in preparation, during the audit/inspection (as agreed with the site) and development and follow-up on the corrective actions;
  • Helps to identify help, expertise and support from outside the site as needed;
  • Site investment projects and new product implementation in terms of Quality and Compliance requirements;
  • Development, update and promotion of Sanofi Global Quality Documentation.

Qualifications and experience:

  • At least first degree qualification in Pharmacy, Chemistry, Biology or relevant Life Sciences;
  • The role requires specific expertise in Industrial Quality and Good Manufacturing Practices;
  • Injectables/sterile experience highly appreciated (Good background in aseptic drug product and device manufacturing);
  • Broad knowledge in global GMP Regulation and Quality requirements;
  • Experience in managing FDA and GMP-inspections;
  • Several years’ operational experience in Quality management/leadership, preferably as a Site Quality Manager;
  • Excellent communication (both written and oral) skills;
  • Excellent command of English;
  • Good leadership and influencing skills to operate in a cross-functional and international environment.

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