Commercial Quality Manager

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

Job Function
Quality

Job Sub Function
Customer/Commercial Quality

Job Category
People Leader

All Job Posting Locations:
São Paulo, Brazil

Job Description
This position is fully On Site and 80% of the activities are in our Sao Jose Dos Campos Site, the candidate must have the availability to go.
Commercial Quality Manager in charge of Logistics Quality Operations Management across Innovative Medicine Brazil LOC organization, internal and external key stakeholders.

The role will ensure alignment and harmonization between Deliver Operations, Supply Chain, Share Service, Commercial, Clinical Trials and Commercial Quality Processes across Local, Regional and Global organizations, supporting IM LOC to successful launches new products modalities and keep quality and regulatory compliance distribution of all portfolios of products.

This position Manages and provides technical leadership to professional level staff. Manages process, develops and oversight routine operational plans to support the strategy of IM Commercial Quality area. Ensure strategy implementation for short-term results and lead Project Management Office and resources for Key CQ area´s

Ensure management, development, implementation, improvement, and ongoing effectiveness of the IM Brasil Commercial Quality Management System to the Commercial Areas, Deliver Operations, Supply Chain, Enterprise Areas in the rule of a business compliance partner.

Leads Commercial Quality Team in charge of logistics operations in order to ensure that processes and product quality goals are appropriately established, monitored, and achieved.

The Manager provides expert guidance in interpretation and integration of Company quality systems for the LOC through corporate and governmental regulations and guidelines.

Specific quality elements of responsibility include suppliers' management, temperature control expertise, projects, and deployment, QMS demands, Management Review, Internal and external Audit, Change Management, CAPA, Distribution Complaints, Purchasing Control, Substance Controlled.

Responsible to manage, host and coordinate Internal and External Audits, Regulatory Inspections, Suppliers and Vendors Qualification strategic oversight for LOC, lead integration of regulatory compliance strategies for QMS at logistic operations and keep high performance and optimization of QMS processes.

In charge of budget management and planning applied for quality logistic operations.

The Manager shall keep the logistics operations quality and regulatory compliance for projects like Trade Customizations and Acquisitions., internal and external Quality Agreements documents which provide authority for product commercialization.

Participates as Brazil Commercial Quality Director representative in the local business board with Q&C voice.

This position provides risk-based Q&C direction, perspective, and support to a range of technical, compliance and business issues pertinent to products, processes, programs and activities. This is a leadership position within the Commercial Quality unit, with key input in the development of strategies, goals, and initiatives, with the authority and responsibility to manage their effective deployment and execution.

Tasks/Duties/Responsibilities

• Ensure management, development, implementation, improvement, and ongoing effectiveness of the IM Brasil Commercial Quality Management System to the Commercial Areas, Deliver Operations, Supply Chain, Enterprise Areas in the rule of a business compliance partner.
• Leads Commercial Quality Team in charge of logistics operations in order to ensure that processes and product quality goals are appropriately established, monitored, and achieved.
• The Manager provides expert guidance in interpretation and integration of Company quality systems for the LOC through corporate and governmental regulations and guidelines.
• Specific quality elements of responsibility include suppliers' management, temperature control expertise, projects, and deployment, QMS demands, Management Review, Internal and external Audit, Change Management, CAPA, Distribution Complaints, Purchasing Control, Substance Controlled.
• Responsible to manage, host and coordinate Internal and External Audits, Regulatory Inspections, Suppliers and Vendors Qualification strategic oversight for LOC, lead integration of regulatory compliance strategies for QMS at logistic operations and keep high performance and optimization of QMS processes.
• In charge of budget management and planning applied for quality logistic operations.
• The Manager shall keep the logistics operations quality and regulatory compliance for projects like Trade Customizations and Acquisitions., internal and external Quality Agreements documents which provide authority for product commercialization.
• Participates as Brazil Commercial Quality Director representative in the local business board with Q&C voice.
• This position provides risk-based Q&C direction, perspective, and support to a range of technical, compliance and business issues pertinent to products, processes, programs and activities. This is a leadership position within the Commercial Quality unit, with key input in the development of strategies, goals, and initiatives, with the authority and responsibility to manage their effective deployment and execution

Required Minimum Education
A minimum of a Bachelor's degree is required. A focused degree in a Pharmacy and Engineer related discipline is preferred. An advanced degree (Post Graduation, Master's/MBA) is preferred.

Required Years Of Related Experience
6-10 years' experience (3-5 years in a leadership role) in Quality & Compliance for Supply Chain (R&D, Q&C, Distribution, Commercialization) or related areas (such as Project Management or Strategic Processes Improvement).

Required Knowledge, Skills And Abilities

• Strong knowledge and background in Pharma Logistic operations including high expertise in Commercial Process (S&OP, Sell in, Sell out, Free Sample and go to market strategies), Supply Chain of cold chain, Controlled Substance process, Quality Assurance, and Health Authority and Health Union interaction. (Required)
• Project Management Office
• People Management
• Advance English Level
• High intermediate Spanish level is a plus

Required Skills
Logistics, Project Management

Preferred Skills
Compliance Management, Continuous Improvement, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Inclusive Leadership, ISO 9001, Leadership, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Processes, Quality Standards, Standard Operating Procedure (SOP), Team Management