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We are searching for the best talent for COMMERCIAL QUALITY SR SUPERVISOR to be in Sao Paulo, Brazil Purpose: The Commercial Quality Senior Supervisor will lead, plans, coordinates and execute quality programs designed to ensure the continuous distribution of products consistent with established standards by performing the following duties personally.
At this level the role has increased responsibility including, but not limited to, additional skills, multiple lines/products, diverse teams, etc.
Support the creation and execution of processes and activities related to fulfilling the quality and regulatory requirements and customer needs for the organization's products and services.
This role reports directly to the Regional Commercial Quality Sr.
Manager Brazil & south LATAM You will be responsible for : * Leads efforts to comply with company policies, procedures, and quality standards; as well as, safety and environmental regulations.
* Lead cross functional teams (internal and external to quality) and resolves inter-functional issues.
* Develops solutions to problems of advanced scope and moderate complexity.
* Administers the change control program and manages local procedures and specifications in the document control system.
* Writes and assists others in writing new or updated operating procedures.
* Generates, identifies, and suggests improvements in significant performance trends.
Reports them to management and appropriate cross functional teams.
* Ensures appropriate technical assistance to the team.
* Executes strategy that includes the management of Customer/Commercial Quality management, implementation of processes, and continuous optimization and improvement in line with regulatory compliance needs.
* Compiles data and prepares reports on system effectiveness for management.
* Develops corrective action plans to resolve issues and verifies implementation.
* Designs and develops procedures and processes for recording, evaluating, and reporting quality and reliability.
* Support daily activities to keep the maintenance of Quality System as: NC and CAPA, Supplier management, Field Actions, Trainings and others.
Support/Lead other activities/projects as required.
* Ensures quality databases and files are regularly maintained to quality records nonconformance, change controls, CAPAs, project outcomes filed in an accurate and timely manner.
* Tracks and trends customer complaints and provides complaint data for quality reports including annual product reviews, and monthly and quarterly complaint reports.
* Coordinates in-depth inspections of interdepartmental facilities and systems.
Support in preparation & readiness (ERC & HA inspections).
* Monitors regulatory inspections (VISA, CRF, etc.)
and supports the technical responsible role when applicable.
Reports inspection findings to department and upper management in a timely fashion.
* Act as Lead Auditor for Internal and Supplier/CDPs Audit.
* Lead and manage complex process issues.
* Support and drive the effective implementation and maintenance of Vision quality requirements, ensuring awareness and continuous education within the applicable areas.
* Understands and applies Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions with team.
* University / bachelor's degree in Pharmacy, Engineering, Technical Discipline or related areas.
* Generally, requires 6-8 Years Work Experience in a Quality, Compliance or Operations Role within Medical Device, Pharmaceutical, Consumer Good, Food or other GMP controlled environment.
* Language: Portuguese and English advanced, Spanish intermediary / advanced.
* Ability to positively influence peers, key stakeholders and management.
* Ability to manage multiple priorities and deliver excellent results.
* Proactive team player, able to take charge and follow-through.
* Regulatory knowledge.
* Excellent written and verbal communications skills.
* Cultural sensitivity as well as an ability to work in a matrix environment.
* Achievement-oriented with a high degree of flexibility and ability to adapt to a changing environment.
* It is preferred that the job holder is a qualified Auditor.
* Previous industry experiences working with different processes that are related to the quality management system.
* Advanced Knowledge in excel / Power BI or other tools that enable automation in data analysis.
* Previous experience working within regional / global organizations.
* Travel availability (up to 20%) upon request.
* Location: São Paulo - Brazil