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

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Bogotá, Distrito Capital, Colombia, Las Condes, Santiago, , Region Metropolitana de Santiago, Chile, Mexico City, Mexico, São José dos Campos, São Paulo, Brazil, São Paulo, Brazil

Job Description:

Tasks/Duties/Responsibilities

• Serving as Temperature Control Subject Matter Expert (SME) for temperature control and humidity requirements and providing Quality input and guidance on Temperature Control and Humidity related issues to Transportation Operations partners
• Liaising with regional and global partners to develop programs enhancing the transportation quality service and compliance requirements. For NPI process, supporting for Quality partners and Transportation as required.
• Support timely and accurate metrics and reports per J& J policies for Transportation team. Identify opportunities to continuously improve quality, cost and time factors within the Transportation organization.
• Oversee the controls and quality standards implementation for Transportation. Ensure local Health Authority requirements are captured and internalized into transportation process.
• Support the successful management of all Health Authority (e.g., COFEPRIS, INVIMA, ANVISA), 3rd party, and JJRC inspections on transportation related matters.
• Liaising with Global Transportation organization and Quality partners for the investigation of temperature excursions and quality issues including subsequent remediation activities for inbound shipments to the region
• Identify opportunities to continuously improve quality, cost and time factors within the Transportation organization.

Required Minimum Education:

• Required: Undergraduate degree in pharmacy, engineering, or scientific discipline.
• Preferred: Master’s degree in engineering, science, or business

Required Years of Related Experience:

• Minimum of 5 years’ experience in the Quality Area.

Required Knowledge, Skills and Abilities:

• Fluent Spanish and English are required
• Experience of regulated healthcare industry in quality transportation, temperature control and/or quality compliance.
• Knowledge of applicable regulations and guidelines, such as ISO 9001, ISO 13485, Good Distribution Practices and other healthcare related regulations.
• Planning skills, and previous project leadership experience
• Problem-solving and decision-making skills preferred
• Experience with issue investigation and remediation.