Manager Commercial Quality Medtech Latam

**We are searching for the best talent for Manager Commercial Quality MedTech LATAM to be in Sao Paulo or San Jose dos Campos or Mexico City or Santiago de Chile or Bogota.**
Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.
When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.
**Purpose**:
Under the general direction of the Commercial Quality Sr Manager, this position is responsible to provide leadership and strategic direction to ensure the success of process execution and management in Latin America Region, with an emphasis on continuous improvement, franchise and commercial team alignment and reliability of the process, following established regulations and procedures.
The overall management responsibilities also require exerting leadership in regional and global projects and initiatives, providing strategic direction to achieve established goals. Role complexity includes, but is not limited to, ability to interact cross segment, cross franchise, connecting and representing LATAM region in global projects and initiatives.
**Reponsabilities**:
Manage Quality Systems
Develop appropriate strategic and process performance measures/targets.
Manage corrective and preventive actions and risk management processes, when applicable.
Establish and maintain global and local relationships with partnering organizations and regulatory bodies.
Operate as a key business partner for commercial teams, understanding business requirements and providing KPIs, as applicable.
Ensures processes managed in a regional level are in place, such as escalation, Customer Services Operation oversight, Samples Management, Field Actions and Stop Shipments, Product Returns, New Product Launches, Product Discontinuation
Responsible to provide leadership and strategic direction to ensure the success of Product Complaintcmanagement with an emphasis on continuous improvement, franchise and commercial team alignment andcreliability of the process to support Product Complaints for the region, following established regulations and procedures.
Ensure compliance of the regional Product Complaint process, including Regulatory Reporting process in the applicable countries.
Provide Product Complaint metrics in management review meetings for the Clusters. Propose initiatives for quality performance improvement.
Be the main point of contact when internal or external audits and inspections are received that can request Product Complaint information and supports the countries with other regional QMS elements under the scope of this position.
Drive complaint vigilance execution in the countries, ensuring the timely intake, processing and closure of Product Complaints records.
Understand current requirements of Regulatory Agencies such as local MOH's, as well as, of standard
organizations.
Analyze new regulations that are issued in the region that may have impact in the processes.
Strategy and Planning
Ability to represent the region in Global and Regional forums, leading functional efforts as required to achieve results.
Relationship Management
Partner with the Clusters, Regional and Functional Community, Business Leaders and Functional areas
Work with business partners and regulators to buid capability and ensure compliance to regulations and quality standards.
Responsible for a continued communication process with the OpCos and commercial franchise representatives,
in order to outline action plans based
**Qualifications**:
Bachelors or Master's degree in Business, Biosciences, Engineering or equivalent field, or health-related discipline
Trilingual (English, Spanish and Portuguese)
Good PC's skills
Minimum 5 years of relevant quality leadership role of which a minimum of 3 years in pharmaceutical, Core competencies required for this role:
Auditing experience
Proven track record of leading or coaching teams to achieve significant quality and process improvements.
Ability to negotiate and influence at various levels in the organization
Strong communicator
Relevant experience in the healthcare or pharmaceutical industry
Proven experience with regulators and quality standard programs. medical device, or healthcare industry.

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