Commercial Quality Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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Job Description:

We are searching for the best talent for Total Rewards Benefits Analyst to be based in Bogotá

The Commercial Quality Specialist will:

• Conducts Supplier & Distributor audits.
• Manage the activities associated with the selection, qualification and approval of products or services suppliers/distributors that are within the scope of the quality management system, in accordance with current procedures.
• Ensure the maintenance of suppliers and distributors requirements qualification.
• Perform transactions in SAP for develop the master data process approval as DDL or GMP.
• Support responses to address external audit and inspections.
• Responsible for reporting, tracking and timely closure of audit (supplier, distributor & external) applicable corrective and preventive actions.
• Management PQI and RC Alerts
• Performs & reports compliance metrics and drive improvement on those metrics.
• Management of technical assistance complaints, ensuring that actions plans are defined and communicated to customers as applicable.
• Support the execution of the change controls, when applicable.
• Support the execution of the complaint management process within the guidelines defined by the company
• Execute the Post Market Surveillance processes: Technovigilance.
• Execute local process for Compliance Alerts (FA, SS, Recall Etc..) ensuring that notifications are carried out and the affected product is handled in a timely manner, in line with current procedures.
• Execute the CRAC (Regional coordinator of field actions) role when applicable.
• Support the implementation of company standards such as: Temperature Control, Loaner Kits, Repack and Relabel, among others as applicable.
• Support activities to execute the Management Review process.
• Ensure compliance with Intercompany Quality Agreements Requirements.
• Support the creation of the purchase orders relative to the process in the Commercial Quality area.
• Document Non-Conformities in the DES; ensuring compliance with the different stages: identification, investigation, cause analysis, correction, implementation of corrective and preventive actions and verification of effectiveness.

Qualifications:

• A minimum of 5 years of work experience in Quality Systems (Good Manufacturing Practices) is required.
• Experience being a Lead Auditor
• Title of pharmacist, life sciences, engineering, or other fields related to health sciences with expertise in Quality Systems.
• English proficiency is required.
• Proficiency in Microsoft Office is required.
• Knowledge in SAP is desirable.
• Strong analytical skills to identify areas for improvement in quality processes.