Senior Manager Commercial Quality

hace 1 semana

Santiago, Metropolitana, Chile Johnson & Johnson A tiempo completo

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At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.

For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health.

In surgery, orthopedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.


We are searching for the best talent for SENIOR MANAGER COMMERCIAL QUALITY to be in Santiago, Chile.

Purpose:


Under the general direction of the Commercial Quality Senior Director, this position is responsible for establishing and leading Johnson & Johnson overall quality management framework and quality system for the cluster, establishing preventive and corrective actions to mitigate potential or actual non-compliance risks and ensuring compliance to attain world-class operational/customer focused capabilities.

The overall management responsibilities also require exerting leadership in regional projects and initiatives providing strategic direction to achieve established goals.

Role complexity includes but is not limited to ability to interact cross segment and representation of the region in global projects and initiatives.

The Senior Quality Manager is responsible to lead activities towards the integration of the quality management systems for applicable country(ies).

This position is responsible for ensuring the QMS requirements are effectively executed in the markets in accordance with local regulations, corporate and segment policies and procedures.

The scope of this role is applicable to the Commercial Quality operations in the cluster (Brazil, Mexico,
Northern Cluster or Southern Cluster

You will be responsible for:

  • Lead the Cluster Commercial Quality organization, including handling, storage, distribution and commercial activities, to ensure a proactive approach to quality assurance and quality systems.
  • Develop appropriate strategic and process performance measures/targets.
  • Manage the overall corrective and preventive action (CAPA) and risk management processes.
  • Establish and maintain global and local relationships with partnering organizations and regulatory bodies.
  • Oversee the management of Standard Operating Procedures, ensuring simplicity, standardization and education across the countries.
  • Operate as a key business partner for quality and process improvement, understand business requirements.
  • Ensure compliance to all applicable quality standards and regulatory requirements
  • Ensure troubleshooting and solutions to quality issues through statistical analysis and process excellence tools.
  • Present case studies and metrics to Cluster Leadership.
  • Coordinate execution of internal audit, and 2nd party audit as needed.
  • Lead the management review process for the cluster as Management Representative. Propose initiatives for quality performance improvement.
  • Drive complaint vigilance execution in the countries ensuring the timely closure of product related complaints cases, quality, and immediate escalation.
  • Understand current requirements of Regulatory Agencies such as local MOH's, as well as, of standard organizations such as ISO.
  • Ensure compliance with the J&J policies and local regulations at the local warehouses and distributors, including external partners. Liaising with other functional areas as appropriate in the execution of these tasks.
  • Partner with Deliver Operations to establish proper surveillance of the distribution activities (cold chain and loaner kits)
  • Effectively work with Cross Segment leadership (functional and commercial) in the deployment and
sustainability of initiatives that will support QMS execution and compliance on designated countries.

  • Management of Pharmacovigilance and Post Market Surveillance (Technovigilance) systems within the cluster. Strategy and Planning
  • Develop a common vision and strategy for Quality and Process Improvement
  • Entrench a process improvement culture within the business. Implement process management practices, verify/validate project results and advocate further use of PE to drive business results.
  • Embed QMS management principles in the organization, creating crossfunctional process improvement teams who effectively complete improvement projects central to these efforts.
  • Engage all company employees in these i

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