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Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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We are searching for the best talent for Commercial Quality Supervisor to be in Sao Jose dos Campos or Sao Paulo, Brazil.

Purpose:

The Commercial Quality Coordinator will coordinate activities related to the Quality System with the objective of maintaining and developing the Business in accordance with Johnson & Johnson' s premises and requirements.

This coordinator will focus primarily on directly supervising activities/processes supporting the logistics operations of the Finished Products Warehouse in São José dos Campos and Cajamar. He/she may be located in the city of São José dos Campos or São Paulo.

He/she will provide support and supervision for Quality in relation to the logistics operations, manage activities related to the Logistics Quality team to ensure temperature control processes, pest control, standard operating procedures, management of Quality records, qualifications and validations, management of licenses, among others.

You will be responsible for:

• Coordination of activities related to handling, storage and distribution supporting J& J IM DCs
• Act as main SME for Temperature control processes, qualification, and controlled substances
• Conduct and support licenses management activities
• Preparation, review and approval of Qualification, Validation and Temperature Control documents;
• Approval, review and evaluation of Non-Conformity Investigation, CAPAs, Change Control and Supplier Qualification processes related to the business;
• Coordination of the preparatory and executive process of Quality Audits (Corporate and External) until the closing and fulfillment of action plans;
• Supervision of Training, Market Complaints, and other flows executed, monitored or controlled by the Business Quality System;
• Approval, review and preparation of Risk Analyses for related processes;
• Ensuring the execution of processes involving Regulatory Compliance;
• Ensuring the statistical evaluation of the Quality System KPIs in order to guarantee compliance with metrics;
• Coordination of local, regional and global Johnson & Johnson initiatives;
• Approval of internal documents or those of Johnson & Johnson stakeholders;
• Contribution to compliance with the company' s Quality/Compliance and EHS requirements;
• Ensuring the execution of processes involving Regulatory Compliance;
• Ensuring mapping and development of process improvements to support stakeholders (GxP and Non-GxP);
• Contribution to meeting the company’s Quality/Compliance and EHS requirements.

Qualifications

Education:

• Bachelor’s degree in pharmacy and/or Biochemistry

• Minimum of 8 years of experience in Quality Assurance in the pharmaceutical industry or related field.

• Solid technical experience in Handling, storage and distribution processes, as well as previous experience in thermal qualifications and Monitoring and tracking of temperature excursions

• Minimum of 1 year of experience with direct leadership of people or Minimum of 2 years of experience with project leadership or indirect leadership.

Experience and Skills:

Required:

• Project Management
• Advanced English (Reading, Writing and Speaking)
• Intermediate Spanish
• Practical knowledge of Quality Tools (5 Whys, Ishikawa, PDCA, etc.)
• Experience with Risk Analysis
• Availability to travel
• Office package (intermediate-advanced Excel)
• Knowledge of Anvisa Health Legislation related to GxP processes and Product Registration
• Advanced knowledge of Thermal Qualifications and system validation
• Leadership profile focused on results and deadlines
• Ability to interact interpersonally, inter-teams and communication skills, providing a harmonious and friendly environment

Leadership ability through the influence of peers and stakeholders

• Ability to act and manage multiple projects/activities simultaneously
• Leadership ability in project assessments, impacts and mitigation plans

Preferred:

• Knowledge of the SAP System – Desirable
• Knowledge of the COMET System – Desirable
• Knowledge of the Power BI System – Desirable
• Advanced Spanish (Reading, Writing and Speaking)