Manager, Quality Assurance Operations
Johnson Johnson Vision Care, a member of Johnson Johnson's Family of Companies, is recruiting for a Manager, Quality Assurance Operations, to be located in Jacksonville, Florida.
Johnson Johnson Vision Care, Inc., - Vistakon® Division of Johnson Johnson Vision Care, Inc., specializes in disposable contact lenses, which it markets under ACUVUE® Brand contact lenses. Ever since ACUVUE® transformed vision correction in 1988 with the world's first soft disposable contact lenses, we've passionately pursued new technologies and the highest quality standards. We're proud that ACUVUE® lenses are worn by more people than any other brand.
Reporting to the Director, the Manager, Quality Assurance Operations will manage the performance of their assigned staff which will ensure that our products meet worldwide government regulations and corporate quality standards. The Manager will define and implement the business unit quality program; monitor the quality program for effectiveness; communicate quality performance and drive quality improvement initiatives. Further, the manager will evaluate the impact of internal and external quality events and provide quality consultation to internal and external customers in support of organizational objectives.
Quality Leadership Development common skills include: Mastering Complexity by defining complex issues; recommending and guiding implementation of functional strategies; managing the department, projects, and day-to-day operations within the area of responsibility; serving as the spokesperson for the functional area; acting as the technical expert for the functional area; making the complex clear and compelling; maintaining conceptual knowledge of all responsible functions and business areas and representing the department or project by providing solutions to difficult technical issues. Innovating by resolving and managing technical and tactical operational problems; establishing key operating practices for the department, projects and functional area while ensuring cross-functional synergy and driving innovation within the functional area. Customer Focused by developing and implementing functional area initiatives to deliver customer value at the lowest cost. Interdependent Partnering by mentoring and facilitating successful team behavior within and across the functional area and typically serving in a project leadership role; managing relationships externally and internally for the functional area; building cross-functional and cross-departmental support and fostering overall group effectiveness. Organizational People Development activities including holding people accountable for measurable results; providing coaching, useful feedback, and direction to direct reports and teams; ensuring and measuring improvement for the development of staff; identifying high potential candidates; fostering harmony within and across the functional area; promoting the business value of diverse perspectives and influencing and persuading to bring about process and technical improvements.
The Manager, Quality Assurance Operations will: manage the performance of assigned staff including managing day-to-day activities, providing training and development, and completing performance evaluations; manage the execution of the nonconformance program including monitoring NC Program for effectiveness, scheduling and facilitating NC Reviews, and documenting nonconformance initiatives; managing the execution of the validation, corrective action and preventive action (CAPA) / root cause investigation (RCI), and change control programs; provide quality consultation to internal and external customers in support of organizational objectives; direct cost improvement projects within the department in support of internal customers; track, report and improve key nonconformance / CAPA / RCI, validation, and change control quality indicators for compliance and efficiency; plan and manage annual spending and headcount budgets; serve as the contact for regulatory groups on scientific issues and audits and perform all other related duties as assigned by management.
Qualifications
A minimum of a Bachelors Degree or the professional work experience equivalent is required; a minimum of eight (8) years of professional work experience within a regulated Quality Assurance environment is required; a minimum of three (3) years of people, process or project management experience or the advanced management training equivalent is required; a working knowledge of FDA and International Regulatory requirements is required; demonstrated working knowledge of quality and operations systems and processes is required; demonstrated excellence in presentation and meeting facilitation skills is required; proven success in the execution and application of quality systems, including the application of statistical principles, theories, and concepts is required; a working knowledge of analytical software such as SPC, SAS or Minitab is required. This position may require up to 10% international and domestic travel and will be based in Jacksonville, Florida.
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