Johnson & Johnson Careers
Manager, Non Compliance (NC) & Corrective and Preventive Action (CAPA)
Santa Ana, California
Requisition ID: 3487181003
Johnson and Johnson Family of Companies is recruiting for a Manager, Non Compliance (NC) & Corrective and Preventive Action (CAPA) position to be located in Santa Ana, CA to support our Johnson and Johnson Vision business.
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.
The Manager NC & CAPA plans, coordinates, and directs NC/CAPA group to ensure compliance and priorities align with strategic business objectives and enables a positive customer experience. Performs the following duties personally or through subordinates:
• Contributes to the development and maintains through continuous improvement the NC/CAPA policies, procedures, tools and guidelines.
• Manages the local review board and ensures that NC/CAPAs meet all J&J and external regulatory requirements while ensuring the effectiveness of NC/CAPAs are robustly and effectively managed.
• Identify and escalate to management any compliance issues and their potential impact across the franchise so that they can be effectively resolved.
• Provide 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.
• Conduct project work and team tasks as required to support strategic business objectives.
• Contribute 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 through continuous improvement NC/CAPA training content and ensuring training is implemented.
• Ensure NC/CAPA program health by providing metrics and reporting to J&J management.
• Responsible for generation and publication of compliance data related to NCs/CAPAs.
• Interface with all sites and site stakeholders for technical assistance and problem solving in areas of NC/CAPA.
• Audits. Provide a high level of professional support during internal and external audits; Serve as a NC/CAPA subject matter expert during audits. Ensure accuracy and completeness of pertinent records and documentation. Responsible for coordination of NC/CAPA data analysis and data review processes for audit readiness.
• Minimum Bachelor’s Degree is required
• Minimum 8 years experience working in non compliance (NC) & Corrective and Preventive Action (CAPA) process, procedures and records is required
• Strong knowledge of FDA 21 CFR and global medical device regulations and standards is required (including but not limited to MDD Regulations, International standards ISO 13485, ISO 14971, JPAL, Canadian, and Brazil Regulations)
• Excellent written and verbal communications and ability to write for external regulators, internal leaders, and others required
• Demonstrated strong expertise with multiple root cause analysis and problem-solving methodologies required
• Experience mentoring, leading or developing team members in the NC/CAPA required.
• Able to communicate clearly with both external regulators and internal staff at all levels of the organization required
• Ability to critically and logically review and analyze documentation required.
• Ability to understand how multi-site and stakeholder relationships affect processes required.
• Ability to work independently on work assignments with minimal oversight 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.
United States-California-Santa Ana-1700 E Saint Andrew Place
AMO US Holdings, Inc.. (6234)