Vistakon® Division of Johnson & Johnson Vision Care, Inc. is currently recruiting for a Senior Compliance Specialist to join its dynamic Quality Engineering team located in Jacksonville, Florida.
Johnson & Johnson Vision Care, Inc. (JJVC) specializes in disposable contact lenses, which are marketed under the ACUVUE® Brand name. 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. And we're proud that ACUVUE® lenses are worn by more people than any other brand.
The Senior Compliance Specialist will plan, coordinate, and conduct quality system audits of JJVC facilities and supportive activities as mandated by federal and international regulations and standards (e.g., FDA QSR, FDA cGMP, ISO, GCP) and Company requirements. Facilities include worldwide operations, including the United States, Europe, and Asia. Provide support to the CMD sector in the performance of audits or audit related activity. Provide regulatory assessments of audit findings and prepare appropriate reports to auditees and management following established procedures. Review and monitor required corrective actions; conduct follow-up activities on required action items. Assist in the preparation and presentation of regulatory compliance training materials for regulatory, quality, technical, and managerial personnel. Providing support for FDA and other governmental or ISO Notified Body inspections conducted at JJVC locations, including readiness activities, front and back room participation/management and general 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. Consult with management, manufacturing, R&D, marketing company 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. Develop and maintains key quality and compliance performance metrics. Participates in developing and presenting departmental materials for Management Review and Annual Product Reviews.
Lead and/or participate on projects and initiatives, such as product design and development activities and operations/production initiatives, providing regulatory compliance guidance with regard to some, if not all, of the following areas: medical devices, API manufacturing, aseptic processing, combination products, and ophthalmic solutions.
Promote a culture of compliance to regulations, standards, and procedures and risk management throughout the organization. Support departmental and franchise objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.
Core responsibilities include:
• Conducts internal and external QSR/GMP/ISO quality system audits and follow-up activities.
• Assists project teams with identification of quality system requirement to ensure compliance.
• Acts as liaison with external auditors during third party/regulatory audits.
• Monitors regulatory agencies for changes in requirements and evaluates impact to the organization.
• A Bachelor’s degree in a scientific discipline OR a Bachelor’s degree and a relevant certification (RAC certification, ASQ - CQA, CQE or SCQE, ISO Lead Assessor) is required.
• A minimum of 4-6 years of working experience in the quality assurance / compliance audit environment required.
• A minimum of 3 years auditing experience is required. Strong communication, organizational, negotiation and interpersonal skills are required.
• Expert knowledge, understanding and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments is required.
• Understanding and knowledge of a broad set of regulations and standards (e.g. 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 will be based in Jacksonville, FL and will require up to 5-10% domestic travel with the potential for international travel.
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Johnson & Johnson Vision Care, Inc. (6094)Job Function