Johnson & Johnson Careers

Manager, Product Safety and Performance

Jacksonville, Florida
Quality Assurance


Job Description

Requisition ID: 5345190125

Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses.


In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. 


Johnson & Johnson Vision is recruiting for a Manager, Product Safety and Performance to be based in Jacksonville, FL.


The Manager will be responsible for Post Market Safety Surveillance data outputs and using data models to drive creative process solutions including date retrieval and ad hoc aggregate reporting and will serve as report owner for medium to large and/or complex assigned reports. The Manager will have in-depth product knowledge, serve as the data point of contact. Daily activities involve leading strategy development, planning, conducting meetings, database searching, aggregate safety analysis and project management/coordination of strategic PMSS solutions, and oversight of work produced by other team members. The Manager will function independently and will have experienced knowledge of applicable regulations and guidelines. The Manager will work independently in formulating creative ideas and solutions on processes, and systems. He/she will serve as a key business partner to the operations teams demonstrating data models to drive innovative process solutions.

  • Implement and deliver new business intelligence tools necessary to evaluate product risk and drive compliance using regulatory GMP and GDP guidelines, policies and procedures.
  • Conduct and inspire frequent formal and informal communication within the team to ensure full engagement and efficient operation.
  • Motivate the team to achieve individual and organization objectives.
  • Champion the development of team members to excel in their performance, both functionally and cross-functionally.
  • Engage with multi-functional business leaders to define and prioritize BI and Analytics requirements.
  • Provide strategic oversight for multi-site 3rd party vendor data outputs ensuring that critical metrics are met.
  • Plan and execute data analysis, data cleansing, data quality, work flow management and data delivery.
  • Collaborate with key business partners to develop and implement effective reports associated with post-launch monitoring of product performance (e.g. complaints, adverse events).
  • Understand end users business requirements and business processes and translates them into particular software and reporting requirements.
  • Assist Post Market Safety Surveillance in risk management activities throughout the product life cycle by generating reports to monitor.
  • Review and monitor master data across functional areas to ensure consistency and application of data standards and quality.
  • Evaluate and execute customer requirements for data management and user needs.
  • Provide direction and guidance regarding the impacts of data standards and data quality.
  • Provide technical expertise in Tableau, SQL. Deliver training to Business users.
  • Lead the overall EU MDR data extraction activities/readiness Project for Post Market Safety Surveillance.
  • Facilitate and guide business users on data management Profile data content, structure, and quality.
  • Generate accurate Post Market Safety Surveillance data outputs.
  • Discover incompatibilities between data sources and the complaint management systems finding data gaps, redundancies, and inaccuracies.
  • Provide Project support to initiatives requiring process, application, or data expertise.
  • Facilitate Business User Forums recommending prioritization and analysis of impacts of business requests relative to data on the project teams. 

Qualifications
  • Minimum bachelor’s degree or equivalent required.
  • Minimum 5 years work experience in regulated industry required.
  • Minimum 5 years’ experience in: designing and developing BI Solutions; required
  • Providing technical expertise in Tableau, SQL; using regulatory GMP and GDP guidelines, policies and procedures; is required
  • Managing projects: gathering and interpreting data and requirements; leading and evaluating Post Market Safety Surveillance data issues is preferred
  • Must have Medical Device & Pharmacovigilance experience as liaison between Post Market Safety Surveillance and the Global Information Technology collecting and documenting business requirements resulting into improved business processes is required.
  • Aggregate reporting experience is required
 
 
 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

 

Location : Jacksonville, FL



Primary Location
United States-Florida-Jacksonville-
Organization
Johnson & Johnson Vision Care, Inc. (6094)
Job Function
Quality Assurance
Requisition ID
5345190125