Supervisor de Qualidade – Reclamações e Vigilância

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Rol rapporteert aan:

Director Global Complaint Vigilance

Locatie:

Latin America, Brazil, Sao Paulo, Sao Jose dos Campos

Werklocatie:

Hybride

Wat je gaat doen

Atualmente estamos com 4 posições abertas para Supervisor.

The COMPLAINT VIGILANCE SUPERVISOR is responsible for processing product quality complaints and supporting day-to-day activities for complaint management for the North America region and globally (as needed) including but not limited to:

Key Responsibilities

• Provide leadership in execution of the complaint management process to the analyst team. Lead all aspects of the complaint process including receipt, evaluation, and coordination with internal (and external sites as needed) to investigate and close product quality complaints.
• Ensure investigations follow procedural requirements, are complete, and closed in a timely manner. Prepare reports and presentations for management and partners.
• Evaluate complaints in alignment with the product quality complaint program. This may include, but is not limited to, trend analysis, assignment of complaint to manufacturing site, review of manufacturing site investigation, complaint closure as applicable, and escalation as needed.
• Complete periodic product complaint trend analysis, Complaint Vigilance reports and presentations per established procedures. Prepare and issue meeting minutes and ensure action items are complete. Assist in Field Sample Management activities, as required.
• Lead projects within the department and communicate effectively with management.
• Act as change agent by leading projects and activities related to Complaint Vigilance process and system implementations and improvements.
• Monitor Complaint Records in the complaint management system to ensure standard processes are being followed and complaints are closed as required.
• Support Annual Drug Product Reports (ADPR) and Monthly Signal Analysis.
• Compile product and lot-specific complaint trending data and complaint closure metrics as requested.
• Provide training and guidance to analysts on complaint vigilance processes and procedures.
• Support internal and external audits and inspections as a Subject Matter Expert as needed.
• As necessary, this position will support the Analyst functions in other Geographical regions for Consumer products.

Required Qualifications

• Bachelor’s Degree in Science/Engineering or a related discipline
• Minimum 6 years of related experience in Quality Assurance and complaint management in pharmaceutical, medical device, nutritional or related industry experience
• Proficiency in the use of computer systems and applications such as Microsoft Office Suite
• Detail-oriented with the ability to document and track corrective actions and complaint investigations.
• Knowledge of regulatory requirements and quality assurance processes in the healthcare industry
• Strong analytical skills with the ability to interpret data and identify patterns.
• Problem-solving abilities and focus on accuracy and precision in data analysis and reporting.
• Ability to work independently and prioritize tasks in a fast-paced environment.
• Language Requirement:  Both Portuguese and English (effectively writing & speaking)

Desired Qualifications

• Excellent communication and interpersonal skills to collaborate effectively with internal and external stakeholders.
• Advanced skills in PowerPoint and Excel including v-look up, H look-up, macros, and pivot tables.
• Problem-solving abilities and expertise with root cause analysis techniques
• Experience supporting manufacturing, packaging, and development operations.
• Experience with systems and tools supporting analysis and reporting including Power BI, Tableau and/or Tableau dashboard development.

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