WEC Cluster NCQ Head
Novartis Farmacéutica, S.A.
Barcelona, Spain
hace 5 días

Job Description

As WEC Cluster NCQ Head you will drive the implementation of the Quality organization, governance & oversight processes within the area of responsibility.

You will ensure implementation of and on-going compliance with applicable regulatory requirements for all GXP areas and the Novartis Quality Manual & Policies as well as with Industry Best Practices and that non-compliance is appropriately addressed via corrective and preventive actions (CAPA) and / or escalation of issues.

And you will ensure an appropriate design and infrastructure of the Quality organization within the respective area of responsibility.

Your responsibilities include, but not limited to :

  • Lead the QA area of responsibility. Ensures appropriate organization. Defines and monitors objectives. Elaborates & monitors budget.
  • Ensure implementation of defined Key Quality Indicators in the area of responsibility to monitor on an on-going basis that relevant processes are in control and compliant.
  • Ensure regularly review and assessment of KQIs at the Leadership Team level and adequate escalation of issues and support their timely resolution and provide quality oversight for deviations and ensure that adequate corrective and preventive actions (CAPA’s) are implemented.
  • Provide quality oversight for planned changes.
  • Ensure adequate regulatory inspection preparation, management and follow-up in the area of responsibility.
  • Ensure communication with local Health Authorities is adequately shared within the organization and commitments tracked and closed on time.
  • Ensure implementation of adequate training within the area of responsibility for all GXP activities by defining, planning and supporting training activities.
  • Ensure that processes are in place to communicate country specific requirements to the Region and headquarter organizations for all GXP areas and assess their implications for the compliance of existing processes & systems.
  • Initiate remediation activities, as necessary, to ensure ongoing compliance.
  • Ensure adequate processing of complaints. Establishes an efficient recall organization as well as ensure development of talent within the local Quality units.
  • Develop adequate succession candidates for the Quality organizations. Drive the implementation of the Cross Divisional Country Quality organization, ensuring governance and process oversight within the Countries under her / his responsibility.

  • Ensure implementation of all local regulatory requirements for all GxP areas (ie. GMP, GDP, GCP, PV) in compliance with Novartis Quality Manual and in alignment with Industry Best Practices.
  • Drive cross-divisional standardization and efficiency gains through innovation and operational excellence projects.
  • Continuously support Commercial performance and new product’s launches across the relevant Countries.
  • Diligently implement the annual Quality Plan and prevent any non-compliance issue, also ensuring that any Deviation will be appropriately addressed via corrective and preventive actions (CAPA).
  • Ensure the Escalation process will be correctly managed and implemented across all concerned Countries to avoid any business disruption (stock out, withdrawal, recall) and / or to compromise Novartis reputation
  • Minimum requirements

  • People Leadership
  • Project Management
  • Representing the organization
  • Collaborating across boundaries
  • Functional Breadth Industry /
  • Business Exposure with EU Health Authorities
  • Risk Management
  • Problem solving
  • Knowledge of project management models and techniques
  • Supplier Relationship Management
  • Quality Management / Quality Assurance
  • Commercial Operation Business savvy

    You’ll receive :

  • Company Pension Plan; Life and Accidental Insurance; Meals Allowance or Canteen in the office; Flexible working hours;
  • Why Novartis

    million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people’s lives?

    We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment.

    Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

    We are Novartis. Join us and help us reimagine medicine.

    Once your application has been received via our Novartis careers portal, your CV will be reviewed by our team of recruiters.

    If shortlisted, if shortlisted you can expect a call from an international number.

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