Director, Quality Product Vigilance

**Job Function**:
Quality

**Job Sub**Function**:
Customer/Commercial Quality

**Job Category**:
People Leader

**All Job Posting Locations**:
São José dos Campos, São Paulo, Brazil, São Paulo, Brazil

Johnson & Johnson is currently seeking a Director, Quality Product Vigilance, to join our Business Quality team located in São José dos Campos, Brazil or São Paulo, Brazil.

United States and Puerto Rico - Requisition Number: R-024355

Belgium, Switzerland, Italy, Ireland, Singapore, China, Australia - Requisition Number: R-025932

Japan - Requisition Number: R-025934

Key Responsibilities:

- Provide oversight of activities associated with end-to-end global complaint handling for non-combo products and measure to complaint timelines
- Direct a team of complaint handling associates which includes INTAKE, INVESTIGATION Outcome, and CLOSURE
- Review and recommend product actions based on complaint investigation data to include initiation of requests for higher level investigations and communication of product risk
- Review periodic trend analyses of complaint data to monitor product performance and ensure appropriate triggers into CAPAs
- Identify and provide guidance for improvements to the end-to-end Complaint Management Process to ensure the integrity, consistency, and compliance of the process
- Oversee complaint investigation with business partners for products and present complex data to executive staff members
- Ensure timeliness of all complaint handling (triage, outreach, closure) in accordance with procedures, standards, and regulations
- Lead processes and timelines associated with QIs/CAPAs/CCs
- Continuously evaluate effectiveness of the end-to-end process to resolve gaps or areas for improvement; convey results of assessments with appropriate actions to management
- Work in partnership with Global Medical Safety, Commercial Operation entities (Call Centers, Local Operating Companies, Business Quality, R/D, Regulatory, Investigation Sites, Brand Protection, Legal, Product Quality Management, etc.) in resolving patient issues and developing continuous process improvement initiatives/organizational changeThe Director leads, coaches, and mentors a staff of professionals**Qualifications**:

- Bachelor’s degree or equivalent in technical, life sciences, or engineering field is required
- A Registered Nurse, Physician Assistant, Biomedical Engineer or other related license/certification/degree, or advanced degree in Pharmaceuticals, Regulatory, Quality, Business, etc., is helpful
- A minimum of 10 years of professional experience in pharmaceuticals, medical device, diagnostics, or related field is required
- A proven experience leading of a team responsible for handling product quality complaints, or related-similar activities, is required
- Direct experience with FDA and/or other regulatory audits/inspections is required
- Experience with corresponding to inquiries associated with regulatory agencies is desirable
- Strong knowledge and understanding of regulatory requirements listed below is highly preferred
- Experience/knowledge of most regulations relative to post market surveillance activities and reporting, such as: ISO 9001/13485/14971, FDA Regulations (21 CFR (parts 4, 11, 210, 211, 600, 601, 606, 610, 803, 806, 820 etc.)), ICH Q8, 9 & 10, CMDR, JPAL, and Medical Devices Directive (93/42/eec, 98/79/EC)) is helpful