Johnson & Johnson Careers
Requisition ID: 1905735311W
Title: Quality Director
Reports to: Senior Director Quality Operations Vision Care
Acts as the Site Management Representative/Responsible Engineering Manager for Visioncare Limerick. Maintains improves and reports on the effectiveness of the Quality System to Senior Management. Ensures manufactured products meets release specifications and conforms to all internal Johnson & Johnson standards as well as regulatory requirements. Serves on the Limerick Leadership team and develops /implements strategic plans to ensure the on-going business growth of Visioncare.
• Leads the Quality function to ensure compliance to all internal and external regulatory requirements
• Manages, the overall direction and performance of the Quality functions.
• Ensures that the Site’s Quality System is established and maintained in harmony with Franchise, MD&D, and Enterprise Quality Systems and in accordance with applicable standards and regulations,
• Reports on the performance of the Quality System to the Organization and Franchise Management.
• Monitors quality system trends and drives the implementation of corrective actions as required.
• Implements Franchise and Global Johnson and Johnson quality policies, strategies and best practices.
• Management Representative/ Responsible Engineering Manager on site for the quality system, for external quality inspections and for ensuring that the quality system is reviewed at regular intervals for suitability and effectiveness.
• Leads and Drive Quality Assurance improvement programmes in conformance with applicable regulatory requirements.
• As a member of the Senior Management Team, contribute to plant management issues and strategic
• Develops the tactical and operational plans for the quality department and ensures that tactical objectives are met in support of strategic targets
• Manages and develops staff and programmes in areas of Validation, Quality Assurance/Compliance, CAPA, Microbiology, Complaint Investigations, Chemical and QC Laboratories areas
• Oversees and leads quality investigations to ensure overall compliance to regulations are met.
• Ensures troubleshooting and solutions to quality issues through statistical analysis and process excellence tools
• Establishes and maintains global relationships with partnering organizations and regulatory bodies.
• Leads cross‐functional teams and provide subject matter expertise to other departments.
• Escalates to the top management on the performance of the quality management system and any need for improvement
• Ensures the understanding and implementation of the quality policy, quality objectives, quality metrics, regulatory and customer requirements throughout the manufacturing site
• Reviews industry publications, articles, and abstracts to stay abreast of developments in industry.
• Estimates budget for the Quality Department and maintain operating costs within constraints of those budgets.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsibilities also include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Education and Experience Required for Role
• Degree qualification in appropriate discipline – science, engineering or technology.
• Minimum of 10 years’ experience in a senior quality management role in a medical device or pharmaceutical manufacturing company.
• Ability to demonstrate standards of leadership as itemized in the JNJ global leadership profile
• Post Graduate qualification in Quality related discipline
• Experience in the use of statistical techniques for Quality Operations
Other Skills and Abilities
• Thorough knowledge of FDA and International Regulatory requirements.
• Excellent organizational, interpersonal, written and oral communication skills required.
• In-depth working knowledge of quality and operations systems and processes.
• Demonstrated excellence in presentation and meeting facilitation skills.
• Proven leadership and problem-solving skills
• Innovative development techniques and strategic thinking abilities
• Ability to prioritize and handle multiple tasks, and to facilitate and resolve cross functional activities and issues.
Note: Responsibilities and accountabilities will vary for all positions. QUMAS procedures will define responsibilities from time to time and each manager is responsible for complying with these processes, which supplant any responsibility outlined below. As such, adherence to company procedures is also a responsibility of this role
Johnson & Johnson Vision Care (Ireland) Limited (8182)