Senior Manager, NC & CAPA Processes

Johnson & Johnson Vision is recruiting for a Senior Manager, NC & CAPA Processes to be located in Irvine, CA; Santa Ana, CA; or Jacksonville, FL. At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating companies, we’ve developed solutions for every stage of life—to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world’s leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good, and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn. The Senior Manager NC & CAPA Processes (Vision) is primarily responsible to plan, coordinate, and direct the NC/CAPA department to ensure compliance and priorities align with strategic business objectives and enables a positive customer experience. Manages the day-to-day operations of the NC & CAPA department for Vision. Oversees the development, improvement and implementation of processes for NC/CAPA, and ensures communication and training are deployed throughout the business related to these processes. Adheres to environmental policy, procedures, and supports department environmental objectives. Essential Functions / Responsibilities of the role are: Contributes to the development, maintenance, and continuous improvement of NC/CAPA policies, procedures, tools and guidelines for Vision. Ensures that NC/CAPAs meet J&J and external regulatory requirements, and that NC/CAPAs are robust and effectively managed. Identifies and escalate to management any compliance issues and their potential impact across the franchise for resolution. Provides supervision and training, as required for direct reports to manage NCs/CAPAs. Support direct reports in gaining knowledge of all applicable standards, regulations, franchise policies, procedures and work instructions, as per individual development plan. Leads project and teams as assigned to support strategic business objectives. Contributes to the development of strategic improvements to the NC/CAPA program while assisting staff in ensuring appropriate training and qualifications have been achieved. Responsible for developing and maintaining NC/CAPA training content and ensuring training content is continuously updated with process improvements and effectively in use. Ensures NC/CAPA program health by providing metrics/analysis and reporting to J&J management on health of system including areas to improve and/or trends for corrective action. Responsible for generation and publication of compliance data related to NCs/CAPAs. Interfaces with Vision sites and site stakeholders for technical assistance and problem solving in areas of NC/CAPA. Participant as a Subject Matter Expert (SME) providing professional support during internal and external audits and developing team to also be SMEs. Provide and ensure accuracy and completeness of pertinent records and documentation including audit requests. Responsible for coordination of NC/CAPA data analysis and data review processes for audit readiness. Responsible for hiring and development of NC/CAPA staff. Qualifications Required: University/Bachelor’s Degree A minimum of 10 years related experience A minimum of 5 years Supervisory experience Ability to review and analyze documentation critically and logically Applied knowledge of FDA 21 CFR and global medical device regulations and standards (including but not limited to MDD, MDR Regulations, International standards ISO 13485, ISO 14971, JPAL, Canadian, and Brazil Regulations) Ability to understand how multi-site and stakeholder relationships affect processes This position may require up to 10% domestic and/or international travel Preferred Advanced degree Demonstrated strong expertise with multiple root cause analysis and problem-solving methodologies Experience communicating with internal or external regulators, as well as internal staff at all levels of the organization 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. Primary Location United States-California-Santa Ana-1700 E Saint Andrew Place Other Locations North America-United States-California-Irvine, North America-United States-Florida-Jacksonville Organization Johnson & Johnson Surgical Vision, Inc (6234) Job Function Quality Requisition ID 2105979267W