Commercial Quality Analyst South Latam

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

We are searching for the best talent for COMMERCIAL QUALITY ANALYST SOUTH LATAM to be in our 3PL facilities in Area de Promoción El Triángulo, Provincia de Buenos Aires, Argentina

Purpose:
Johnson & Johnson Vision is recruiting for a Commercial Quality Analyst South LATAM to work in Cidade Autônoma de Buenos Aires - Argentina.

The Commercial Quality Analyst South LATAM will execute processes and activities related to fulfilling the quality and regulatory requirements and customer needs for the organization's products and services and maintains quality assurance programs, supplier systems, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives. Provides support for quality projects. Ensures and maintains a state of inspection readiness.

This role reports directly to the Commercial Quality Sr. Supervisor Brazil & South LATAM.

Key Duties and Responsibilities:

- Leads efforts to comply with company policies, procedures, and quality standards; as well as, safety and environmental regulations.
- Develops solutions basic scope and intermediate complexity. Assists in writing standard operating procedures.
- Ensures appropriate technical assistance to the team.
- Act as a Qualified Person for Argentina (ANMAT and the Province of Buenos Aires) to executes activities related to import and product release processes (arises from the instructions for the procedure for authorizing a medical products warehouse).
- Executes techno vigilance process and management with health authorities for the region.
- Provides complaint/adverse events data for quality reports.
- Supports in activities related to recall & field actions.
- Executes the oversight of JJVC 3PL and Distributors for South LATAM region.
- Assists in the documentation of corrective action plans and monitors implementation and follows up on closure of corrective and preventive actions.
- Assists the impact assessment of the regulatory requirements applicable to Distribution Center/3PL.
- Supports internal/external and suppliers audit activities, responses and compliance with due dates.
- Ensures the updating and maintenance of the regulatory documentation related to the regulatory agency related under your responsibility.
- Monitors trends, identifies issues, recommends and implements appropriate actions. Assists in the development, implementation and review of standard operating procedures for interactions with Distribution Center/3PL.
- Monitors regulatory inspections and reports inspection findings to department and upper management in a timely fashion.
- 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.

**Qualifications**:
**Education**:

- University / bachelor’s degree in Pharmacy and available to assume technical responsibility at ANMAT and the Province of Buenos Aires.
- Generally, requires 2-4 Years Work Experience in a Quality, Compliance or Operations Role within Medical Device, Pharmaceutical, Consumer Good, Food or other GMP controlled environment.
- Language: Spanish fluent and English intermediate/advanced

Experience and Skills

Required:

- 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.
- Great technical knowledge in quality & regulatory compliance with experience in the techno vigilance process.
- Management skills with Health Authorities.
- 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.

Preferred:

- Previous industry experiences working with different processes that are related to the quality management system.
- Knowledge in excel / Power BI or other tools that enable automation in data