Description
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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Quality AssuranceJob Category:
People LeaderAll Job Posting Locations:
São Paulo, BrazilJob Description:
JOB POSITION SUMMARY
Plans, coordinates and conducts quality programs designed to ensure the continuous distribution of products consistent with established standards by performing the following duties personally or through subordinates. At this level the role has increased responsibility including, but not limited to, additional skills, multiple lines/products, diverse teams, etc.
This role reports directly to the Sr. Regional Commercial Quality Manager Brazil & South LATAM.
DUTIES & RESPONSIBILITIES
- Leads efforts to comply with company policies, procedures, and quality standards; as well as, safety and environmental regulations. Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws.
- Responsible for overseeing the quality operations and for supervising the daily activities of the quality team. Trains, plans, schedules, and assigns tasks, evaluates performance, and supports problem solving. Conducts and tracks quality investigations and process deviations and follows up to ensure corrective action has been taken. Supervises investigation of non-conformities related to the operational processes and quality of your responsibility.
- Monitors appropriate metrics and measures to track compliance against established QMS elements, including escalation of issues. Supports the JJV suppliers’ program.
- Support on translation of global documents that impacts JJV quality operations. Lead projects.
- Provides support to Supply Chain in Quality related subjects (monitors trends, identifies issues, recommends and implements appropriate actions) and leads the quality specialists located in JJV Distribution Center / 3PL and also the Distributors in the region (Brazil, Argentina, Uruguay, Paraguay, Chile, Ecuador and Peru).
- Conducts or oversees Internal, Supplier and Distributor Audits as Lead Auditor.
- Coordinates in-depth inspections of interdepartmental facilities and systems. Support in preparation & readiness (ERC & HA inspections) and document in Curve system.
- 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.
- Assists in conducting and developing training in operation processes. Approves changes to documentation and processes. Reviews, for approval or rejection, all procedures or specifications impacting on the quality of products stored and distributed products. Ensures that quality operations databases and files are maintained regularly. Performs other related functions.
EXPERIENCE & EDUCATION
- University/Bachelors Degree or Equivalent. It is preferred that the job holder holds a further qualification in Science, Engineering, Technical discipline.
- Generally Requires 6-8 Years Work Experience in a Quality Role within Medical Device, Pharmaceutical, Consumer Good, Food or other GMP controlled environment.
- Previous experience in a Quality / Regulatory Role is essential.
- Language: Portuguese / English advanced. Spanish intermediary.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES AND AFFILIATIONS
Comprehensive knowledge of Quality Systems and Regulations. Strong communication, interpersonal and organizational skills. Thorough understanding of regulatory / compliance requirements for specific region. Good problem-solving skills. Demonstrated management abilities.
It is preferred that the job holder is a qualified Auditor.
LOCATION & TRAVEL REQUIREMENTS
Location: Brazil
Travel: Required to DC/3PL that is under your responsibility.
Required Skills:
Preferred Skills:
Business Savvy, Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Human-Centered Design, Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Risk Assessments, Standard Operating Procedure (SOP), Team Management