Responsible for overall quality and compliance leadership Johnson & Johnson Vision (JJV) country Marketing Company (MC) or Local Operating Company (LOC) or commercial entity. This will include all distribution centers, warehouses and third-party logistics operations affiliated with JJ Vision.
Responsible for implementing and managing the Johnson and Johnson Vision country Quality Management System for the Regional and Commercial Quality organization. Position will be responsible for all in-country JJ Vision Quality & Regulatory compliance including compliance to the Franchise. Position will partner with JJ Vision Franchises Quality, Regional JJ Vision leadership and the Johnson & Johnson Enterprise Quality organization to drive improvements in Quality and Compliance. Management of programs and projects to ensure the achievement of planned quality objectives. Selects trains and develops key staff to ensure availability of resources to support the QMS objectives. Makes decisions on significant quality and products issues. Prepares department budgets and executes against approved plan. Responsible for the management of on-site external agency audits to ensure maintenance of licenses and standards. Position will lead, coordinate and prepare for external audits. Position will partner with Jacksonville (Vision Care) and Santa Ana (Surgical Vision) based Product Quality Managers, Regional JJV leadership, MD&D Commercial Quality Organization, Consumer Commercial Quality Organization and Enterprise Regulatory Compliance (ERC) group to drive improvements in Quality and Compliance.
Proactively monitors, analyzes and improves all aspects of quality compliance, quality control and customer complaint process in order to drive the Total Customer Experience. Responsible for escalation of relevant issues within country to the Franchise, facilitating the non-conformance and CAPA processes, ensuring compliance with customer complaint process, and all quality assurance components of MC/ LOC and distribution networks. Position will communicate and partner with other Regional Quality personnel in-order to implement a worldwide quality management system for JJV, analyze global trends or early warning signals, and proactively prepare for external audits. Position will be the country VOC for product quality and regulatory and quality compliance. Position will create in-country product quality and compliance KPI’s and implement improvement plans. Position will analyze global trends or early warning signals and proactively prepare for governmental audits. Position will develop and implement in-country quality procedures as necessary.
Finally, this position will adhere to environmental policy and procedures and support department environmental objectives.
- 12 years & above working experience in technical / quality / regulatory role in the Medical Device Industry preferred.
- Minimum 8 years & above supervisory experience required
- Ability to travel up to 30% required
- Excellent project management skills required
- Excellent problem-solving skills required.
Excellent communication, interpersonal and organizational skills required.
Excellent understanding and application of principles, concepts and practices of statistical methods preferred.
- Strong leadership, coaching skills required.
Demonstrated management abilities required
Thorough understanding of in-country regulatory / compliance.
- Experienced with direct communications and interactions with end customer/ user.
- Flexible in undertaking tasks and working hours.
- Ability to use own initiative and make the difficult decisions
Can lead and drive the changes necessary to support and build the business