Regional Director of Quality - EU Operations Biologics

Regional Director of Quality - EU Operations Biologics

Catalent

Cham, Brussels, Limoges, Anagni or Gosselies

 

Position Summary

The regional Director Quality, EU Biotherapeutics is accountable for ensuring the successful delivery of quality and regulatory strategy and operational excellence at Catalent EU Biologics facilities. This is accomplished through leading through others by building and maintaining strong relationship with BU VP of Operations, PD, Finance and other functional leads as well as the supporting Site Quality Heads and Site General Managers. The incumbent will have the necessary leadership and technical depth/background to provide technical guidance for the site deviations, projects, operational excellence, and act as the regional representation for customers in the region. In addition, the incumbent will provide leadership for significant projects including Due Diligence, site integrations and other regional projects as necessary. The position works with various functions across Catalent as a knowledgeable resource for regulatory compliance and participates in or leads targeted compliance improvement teams as needed.

The Role

  • Work with Site Quality Directors and General Manager to translate and operationalize Quality, Regulatory and Compliance strategy into deliverable actions for individual sites while maintaining a robust "One Catalent" QMS;
  • Partner effectively with other Quality and Functional leaders (Manufacturing, Operations, etc.) and Site General Managers to develop and maintain a meaningful and robust Patient First and Quality culture across all aspects of the business;
  • Champion, through clear and visible advocacy, Catalent's Quality Management System (QMS), and ensure strong technical and leadership capability at all levels of the Quality organization;
  • Ensure appropriate metrics and reporting/escalation processes are in place and being utilized to drive and improve required operational execution and performance levels and drive appropriate corrective actions planning;
  • Oversee and deliver on enterprise projects and IT systems supporting GxP activities;
  • Perform due diligence and provide Quality and regulatory guidance to the larger team and suitability and fit. Provide and execute on integration activities for regional purchases;
  • Facilitate Quality Best Practice sharing across the Biologics Network and with the rest of Catalent;
  • Participate in the weekly Biologics SQDC (Safety Quality Delivery and Cost) calls with the sites to make sure metrics are reported timely and consistently & coordinate the pre-work before the calls (specific topics of interest, etc.).

The Candidate

  • Bachelor's or master’s degree in science, pharmacy or related discipline is required. MBA or PhD as educational background is a plus;
  • Extensive experience (10+ yrs) in aseptic operations, Biologics operations and large molecule analytics. Cell and Gene therapy experience a plus;
  • Proven experience in managing a regional quality function in Biologics or Vaccines;
  • Proven experience in driving substantial improvements of quality performance across a broad range of initiatives including development and recruitment of talent, process improvements, elimination of exceptions/SOP standardization;
  • Knowledge of global cGMP regulations including FDA, EMA, ANVISA, and other Tier 1 regulatory agencies with a continuous improvement mind-set and disposition is critical;
  • Leads through influence and able to leverage the matrix.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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