Johnson & Johnson Careers

LATAM REGIONAL CONSUMER QUALITY SR DIREC

São José dos Campos, Brazil
Quality Assurance


Job Description

Requisition ID: 8377181128

General

The Senior Director, LATAM Regional Quality & Compliance leads the Business Quality function for the brands within LATAM (may include Drug, Medical Device, Combination Drug/Device, Cosmetics and services to ensure that products and services in commercial distribution meet the relevant Health Authority regulations, J&J Standards, Policies and Procedural requirements. This position provides end-to-end oversight of quality and compliance of products and services in Latin America through partnerships with Make Q&C, Source Q&C, R&D Q&C, Consumer Logistics Services Q&C, and Consumer Care.  The role has responsibility for the following businesses:   BABY, BEAUTY, SELF CARE(OTC), FEM CARE, ORAL, COMPROMISED SKIN

 
Management Responsibility

Serve as the Management Representative for Latin America within the Johnson & Johnson Consumer Family of Companies. Responsible for participating in development and deployment of the Business Quality Strategies and Plans and assuring the integration/alignment of the business strategy with the strategies of regional quality functions.

Responsible for Management Review of the Quality System at the Latin America Supply Chain team (LASC) and Latin America Operating Committee (LAOC) and Escalation to Management on key product issues and critical Quality System failures. Collaborates with the Make and Source Q&C organizations to monitor and bring forward issues with potential to impact product supply, quality, compliance or reputation. Responsible for calling Quality Review Board to review key product issues with the potential for market impact (recall, market withdrawal, product discontinuation, and significant product rejections).

Quality Systems Implementation and Integration

Ensures the Quality System meets all requirements for the Company and its product portfolio, monitors and ensures ongoing Quality System effectiveness and ensures ongoing improvement. Proactively understand, through ongoing monitoring of external regulations and standards, (including as applicable FDA, ISO, USP, regional regulations) current regulatory expectations. Ensure the establishment of new/revised Quality System Policies and Procedures driven by changes in regulations, J&J Standards, product portfolio or business strategies to assure that the products marketed by the Company meet all relevant company and external regulatory requirements. Actively participate in the implementation and integration of the North American Quality System and, as appropriate, global standardization efforts.

New Product Quality Assurance

Participates as Quality representative on New Product Steering Committee / Regional Franchise Marketing meetings representing Quality Assurance on the Board; Creates a strong partnership with R&D to ensure new products launched are robust and the elements that are critical to quality are built into the raw material and product documentation and specifications; ensures robust processes and testing methodologies are transferred to the quality laboratories and manufacturing. Collaborates with the Make and Source Q&C organizations to ensure the proper validations are executed prior to new product launch and that the manufacturing site is fully qualified. Collaborates with the LATAM Raw Material Center, Procurement, Make and Source Q&C organizations to ensure all new and existing raw materials and components and suppliers are fully qualified prior to launch of a new product. Approves the Authorization for Product Release (APR) prior to new product launch and provides Q&C approval of design changes over the life of product.

QA Strategic Support to Business

Provides strategic QA input to the Executive S&OP process; Gross Profit Improvement Initiatives; and other business processes.

Licensing and Acquisition — Due Diligence

Conducts due diligence reviews, assessments and audits for new business opportunities. May lead integration of new products/businesses and participate in divestures as needed to support business objectives.

Complaint Vigilance

Chairs the Company (Franchise) quarterly Complaint Vigilance Review Board (CV RB) meetings. Ensures issues and trends identified through post market surveillance activities are appropriately addressed through remedial or corrective actions as appropriate and

Quality Indicators revision meeting
Attends Quality Indicators revision meetings to ensure issues and trends are being addressed in a timely and effective manner and elevated for executive management attention and action when needed.

Essential Functions:  

Organization Management / People Development:  Conducting team meetings, 1:1’s, Conversations #1-#5, organizational development,

Cross Functional Engagement:  Participation in Latin America Supply Chain (LASC), Latin America Operating Committee (LAOC), Latin America Executive Committee (LAEC) and LATAM BQ Cross Sector related activities.

Quality Engagement:  Leading forums to ensure collaboration across Q&C organizations: Make Q&C, Source Q&C, R&D Q&C, CLS Q&C, and Consumer care

Strategy Development: Working on LATAM SC Operating Plan and Consumer Q&C Strategies

Quality System Management:  Preparing and executing QSMR, participation in required forums (CAPA Review Board, Complaint Vigilance Review Board, Product Assessment Meetings PAM/ Quality Review Boards QRB’s)

Employee Required:  ComplianceWire, Instructor led Training Courses,



Qualifications
Education:
  • Minimum B.S. in a life science or technical discipline. Advanced degree (e.g. M.S., Ph.D., M.D.) or graduate study highly desirable.
Experience:  
  • Minimum of 12 years of experience in various fields in the Pharmaceutical, Consumer/Personal Products, Device or Healthcare industry with a minimum of 10 years in a Quality Assurance, Compliance, R&D or other Technical Leadership role. Min of 8 years leading and managing teams
  • Significant experience in the development and execution of Quality and Compliance strategy, Supply Chain functions, product lifecycle management and establishing productive working relationships with Health Authorities.
  • Proven experience on a business board
  • Proven experience in leading and managing a large, diverse community of professionals in a global environment
Knowledge, Skills and Abilities:   
  • Seasoned business leader, decision maker and constructive challenger.
  • Outstanding communication, influencing and partnering skills.
  • Proven experience in risk management and collaboration in an international environment
Location of Role: Brazil

Language Requirements: Spanish, Portuguese and English

Travel Requirements: Up to 20% domestic and international travel is required based upon business needs

Primary Location
Brazil-São Paulo-São José dos Campos-
Organization
J&J Brazil (7680)
Job Function
Quality Assurance
Requisition ID
8377181128