Johnson & Johnson Vision Care, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Manager of Regulatory Compliance located in Jacksonville, Florida.
Johnson & Johnson Vision Care (“JJVC”) specializes in disposable contact lenses, which it markets under ACUVUE® Brand Contact Lenses. Ever since the ACUVUE® Brand 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.
Responsible for directly managing the global franchise internal audit and regulatory compliance functions, including development of goals and assuring management oversight and governance. Assure internal audits and assessments are conducted for compliance with the applicable international regulatory requirements (FDA QSRs, FDA cGMP, ISO 13485, Japanese MHLW, Brazilian ANVISA) for the company's products, including medical devices, combination products, and pharmaceuticals.
• Functional responsibilities include internal audits, 3rd party inspection readiness and management, and Quality System compliance training programs.
• Lead and participate on cross-functional and global teams representing key stakeholders in developing and managing policies, standards, and procedures. This includes developing procedures and practices that can be deployed globally.
• Partner with JJVC sites and related organizational units to ensure that regulatory compliance procedures are compliant, effective, and efficient. Utilize stakeholder input to ensure that the overall enterprise objectives are achieved.
• Represent JJVC on JJRC teams and working groups. Provide input into segment initiatives. Interpret and integrate resulting segment policies and standards into JJVC global operations.
• Manage FDA and other governmental or ISO Notified Body inspections conducted at JJVC locations, including pre- and post-inspection support, as requested. Serve as company representative during regulatory inspections. Support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary.
• Manage associated assessment and remediation activities as a result of internal and external assessments. Align and deploy JJVC Quality System procedures (worldwide) in accordance with segment and enterprise standards.
• Consult with management, manufacturing, R&D, and laboratory staff to help formulate and implement proactive regulatory compliance strategies and controls.
• Maintain a leadership presence with government regulators and external professional organizations in order to monitor and influence regulatory issues. Interpret and integrate regulatory changes (FDA/ISO/ ANVISA/JPAL/CMDCAS, etc.) into franchise procedures.
• Develop and maintain key quality and regulatory compliance performance metrics. Participate in developing and presenting departmental materials for Management Review.
• Actively participate in continuous improvement efforts for global continuous improvement activities.
• Supervises staff responsible for the preparation and presentation of regulatory compliance training materials for regulatory, quality, technical, and managerial personnel.
• Promote a culture of compliance to regulations, standards, and procedures and risk management throughout the organization. Support departmental objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures. Direct, supervise and train staff of Compliance Specialists/Auditors.
Major responsibilities include:
• Manage and lead assessments, analyses, alignment, and implementation activities for regulatory compliance procedures across the organization and provide directional input into segment and enterprise standards.
• Direct, supervise and train staff. Develop and monitor development and training plans.
• Assist project teams with identification of quality system requirements to ensure compliance with regulations.
• Acts as liaison with external auditors during third party/regulatory audits.
• Monitor regulatory agencies for changes in requirements and evaluate impact to the organization. Qualifications
• A minimum of a Bachelor's degree is required; a degree in a technical field is preferred; an advanced degree is an asset.
• A minimum of 8+ years of business experience is required.
• A minimum of 4+ years of working experience in the quality assurance / compliance audit environment is also required.
• Proven track record of successfully leading and/or facilitating FDA inspections, both front room and back room is required.
• The ability to effectively manage people (both directly and indirectly) is an asset.
• Experience managing projects that include cross-functional teams representing diversified areas is preferred.
• Strong communication, organizational, negotiation and interpersonal skills is required.
• Expert knowledge, understanding and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments is required.
• A certification in RAC, ASQ - CQA, CQE or SCQE, and/or ISO Lead Assessor is an asset.
• Understanding and knowledge of a broad set of regulations and standards (21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; Canadian CMDCAS; Japanese PAL; 21 CFR 50, 54, 56, 58; 21 CFR 812 and 814; ICH GCP Guidelines, etc.) is required.
• This position may require up to 15% domestic and international travel and will be based in Jacksonville, Florida.
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Johnson & Johnson Vision Care, Inc. (6094)Job Function