Johnson & Johnson Careers
Director QS for Business Regional QA JJ Vision
Requisition ID: 1805670784W
Position: Director, Program Management QMS Integration
Reports to: Sr. Director, Regional and Business Quality
Johnson & Johnson Vision
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.
Responsibilities include but are not limited to:
- Providing region-wide leadership for implementing and continuously improving quality, Quality Management Systems and compliance
- Representing J&J Vision to other J&J departments (e.g. ERC), as well as external audiences for audits, registrations, and local regulators and Health Authorities
- Management of the Authorized Representative functions
Overall responsibility for the project is to integrate two QMS packages at the RQOs. Responsible for the implementation of a QMS at the marketing entities to meet the Johnson & Johnson requirements for these LOCs (local operating companies). Support the Regional QA Heads to transition the distribution centers from the JJ SV 3 PL model to the CLS model.
Responsible for supporting the Regional QA Heads to align and implement the Johnson and Johnson Vision Quality Management System per the defined strategy and agreed timeline. Responsible for leading a dedicated team to define and implement the JJ Vision QMS at the JJSVV LOCs. The position will partner with J&J global Vision Quality, Supply Chain (SC) and commerical organizations including partnering with leadership teams to drive and implement these key objectives for the JJ Vision organization.
Selects the team to run and manage the programs and ensures the availability of resources to support the project objectives. Develops the project plan to make decisions on significant quality and product issues. Prepares department budgets and executes against approved plan(s). Responsible for the management of on-site external agency audits to ensure maintenance of regulatory approvals, licenses, standards. Position will lead, coordinate and prepare for external audits. Position will partner with J&J Vision global Q&C and SC organizations, and where applicable J&J Enterprise organization (Quality Systems and Regulatory Compliance) to drive continous improvements in quality and compliance.
Proactively monitors, analyzes and improves all aspects of quality compliance, quality control, Quality Assurance and the customer complaint coordination processes in order to drive the Total Customer Experience. Responsible for escalation of relevant issues within the region to the global Q&C organization per procedures, facilitating and/or overseeing compliance to the non-conformance and CAPA processes, ensuring compliance with customer complaint and reporting process, as well as all quality assurance components of the LOCs and distribution networks.
Position will communicate and partner with other Regional and Business Quality professionals in order to implement a worldwide quality management system for JJVC and JJSV, analyze global trends or early warning signals, and proactively prepare for external audits. Position will be the VOC for the region for product quality, regulatory compliance. Position will create product quality and compliance Key Performance Indices (KPI) specific to the region and implement improvement plans. Position will analyze global trends or early warning signals and proactively prepare for governmental audits. Position will develop and implement quality procedures specific to the region as necessary.
- Bachelor’s Degree – Technical discipline (e.g. Engineering, Chemistry, Life Sciences, etc.)
- Advanced Technical Training in DOE, Statistics
- 15+ years working experience in technical / quality / regulatory role in the Medical Device Industry.
- Ability to travel up to 50% required
- Excellent project management skills required
- Excellent communication, interpersonal and organizational skills required
- Understanding and application of principles, concepts and practices of statistical methods preferred
- Demonstrated management abilities required
- Thorough understanding of regulatory / compliance requirements for specific region
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