J&J Family of Companies Director, Regional & Business QA EMEA - J&J Vision in Limerick, Ireland
Job Title: Director, Regional & Business QA EMEA
Department: Quality Assurance
Reporting to: Snr Director, Regional & Business QA EMEA
Location: This position can be located at a J&J Vision site - EMEA (Ireland, United Kingdom or Germany)
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
The successful candidate will be responsible for the overall quality and compliance (Q&C) leadership within the EMEA region for Johnson & Johnson Vision (JJVC and JJSV). Responsibilities will include government interactions when required, Q&C oversight of Local Operating Companies (LOCs) and commercial entities. This includes all distribution centers, warehouses and third party logistic operations affiliated with J&J Vision for the region of responsibility.
Implementing and managing the Johnson and Johnson Vision Quality Management System for the Regional and Business Quality organization.
Responsible for all J&J Vision Quality & Regulatory quality and compliance requirements within EMEA including compliance to the all applicable J&J Enterprise and local government regulatory agency regulations.
Partner with J&J global Vision Quality, Supplie Chain (SC) and commerical organizations (when required), including partnering with Regional JJVC and JJSV leadership teams to drive continuous improvements in quality and compliance in their respective region.
Lead and manage various activities, programs and projects to ensure the achievement of planned quality objectives.
Selects, trains and develops talent to ensure needed successions and bench strength, depth and availability of resources to support the QMS objectives is development and maintained.
Makes 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.
Lead, coordinate and prepare for external audits.
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.
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.
VOC for the region for product quality, regulatory compliance.
Create product quality and compliance Key Performance Indices (KPI) specific to the region and implement improvement plans.
Analyze global trends or early warning signals and proactively prepare for governmental audits.
Develop and implement quality procedures specific to the region as necessary.
Finally, this position will adhere to environmental policy and procedures and support department environmental object
Provides region-wide leadership for implementing and continuously improving quality, Quality Management Systems and compliance. Management of any ISO 13485 or ISO 9000 requirements (40%)
Represents 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 (35%)
Communicates to all levels of the organization (10%)
Management of the Authorized Representative function(10%)
Performs other related duties as assigned by management (5%)
Bachelors Degree – Technical discipline (e.g. Engineering, Chemistry, Life Sciences, etc.)
10-12+ years preferred 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 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 regulatory / compliance requirements for specific region.
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
Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-United Kingdom
Johnson & Johnson Vision Care (Ireland) Limited (8182)