Johnson & Johnson Careers
Senior Quality Manager
Anasco, Puerto Rico
Requisition ID: 2134180523
Johnson & Johnson Vision, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Manager.
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.
As the Senior Quality Manager, you will:
• Oversee the personnel, definition and deployment of Quality Systems within the primary areas of responsibility to ensure compliance and to support the effectiveness and efficiency of the system and its requirements.
• You will lead the effective management and development of the Quality System requirements including training, Non-Conformances (NC), Corrective and Preventive Actions (CAPA), Management Review, Process & Equipment Validations, production, process and material controls.
• Serve as the Subject Matter Expert (SME) for Quality Assurance, support the inspection team during internal and third-party inspection, and work with multi-functional teams to establish effective plans and ensure uninterrupted support to the quality and business system in a complaint environment.
• Execute supervisory related activities (i.e. timecard management, activity planning, handling of disciplinary actions) and ensure all direct personnel are properly trained to perform their assigned functions.
• Serve as a consultant in the Quality and Compliance field for applicable site products, processes, and global projects.
• Provide support on activities, documents and records requiring Quality Systems review and approval as necessary.
• Liaise with Fundamental Operations and Process Management teams to ensure consistent alignment, implementation and rollout of new processes and procedures.
• Build a strong, productive and effective team. This includes: setting priorities, resolving workload matters and ensuring proper execution of Quality System processes.
• Create and review documents, Standard Operating Procedures (SOP), practices, and new device approaches.
• Identify, prioritize, and execute quality and cost improvement projects that support business goals by using Engineering principles, tools, and practices.
• Provide guidance to functional organizations and project teams across the Business on the interpretation and application of regulations and standards related to Quality Systems, while ensuring the implementation of new or existing regulations.
• A minimum of a bachelor’s degree is required, preferably in Engineering.
• Professional Engineer/Engineer in Training License or Quality related certification is preferred.
• A minimum of eight (8) years of experience in Quality Engineering or Quality Assurance management functions within the Pharmaceutical or Medical Device industry is required.
• Experience managing and hosting of regulatory bodies and agencies is required.
• Experience with validation, current Good Manufacturing Practices (cGMP) or Good Laboratory Practices (GLP) in an FDA regulated environment is required.
• Experience with Quality Systems is required.
• Experience in project management is required, preferably working with multi-site projects or programs.
• People management experience is required.
• Proficiency in English and Spanish (oral and written) is required.
• Computer-literate in the use of Microsoft Office tools (Word, Excel and PowerPoint) is required.
• This position requires up to twenty-five percent (25%) of domestic and international travel.
• Ability to work extra hours and weekends as per operational needs is required.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Puerto Rico-Anasco
AMO Puerto Rico Manufacturing, Inc. (Branch) (7239)