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Job Description:

Commercial Quality Manager in charge of Quality Management System Excellence across J&J IM Brazil.

The role will ensure alignment and harmonization between Deliver Operations, Supply Chain and Commercial Quality Processes, supporting LOC to successful launches new products modalities and keep quality and regulatory compliance distribution of all Janssen portfolio 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 JNJ IM Commercial Quality area. Ensure strategy implementation for short-term results and leads projects.

Responsibilities

• Ensure management, development, implementation, improvement, and ongoing effectiveness of the JNJ IM Brasil Commercial Quality Management System to the Commercial Areas, Deliver Operations and Supply Chain in the rule of a business compliance partner.
• Leads Commercial Quality Team in charge of Quality System Management Excellence 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.
• Working closely and collaboratively with the Regional and Global Q&C structure, providing the basis for the execution of strategies and the oversight of projects implementations.
• 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.
• This position has direct responsibility for a team of professional employees at multiple levels of experience, training, and skills. The Manager is expected to manage team member development, performance, and empowerment consistent with the goals and expectations of Janssen Commercial Quality Brazil.

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).
• Strong knowledge and background in Pharma Quality 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, Product release, Quality Assurance, and Health Authority and Health Union interaction.
• Mandatory experience in Pharma

Required Skills:

Preferred Skills: