MD&D-Manager, Global Complaint and Service Management Process-00000TDP
Description
Medical Devices & Diagnostics Global Services, LLC, a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Manager, Global Complaint and Service Management Process. The preferred location for this position is Bridgewater, NJ; alternatively the position may be located at any MD&D site globally. Less than 25% domestic and international travel may be required, based on business needs.
Medical Devices & Diagnostics Global Services, LLC., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD&D Supply Chain supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
J&J has implemented a global transformational Complaint and Service Management program that focuses on quality as a competitive advantage. It will deliver a common process, organization, and technology solution that supports medical device and diagnostic products in order to increase patient safety, meet global regulatory commitments, and improve operational efficiencies and customer satisfaction.
The Manager, GCSM is responsible for the base business aspects of the Global Complaint and Service Management System. This includes ongoing responsibility for all procedural documentation, owner of User Roles, etc. She or he ensures that appropriate metrics are defined and measured to enable monitoring and continuous improvement. Provides global leadership and guidance for the execution of processes, interpret global regulatory requirements, emerging industry trends, and apply risk management strategies. Quickly and consistently identifies opportunities that enable the organization to respond to and anticipate to regulation and emerging trends.
The Manager, GCSM is expected to have deep knowledge of the end-to-end complaint management, service, inquiry and analytics processes and platform. He or she will work independently and exhibits strong ability to collaborate with Business Partners (Franchises, IT, Market Affiliates, etc.) to provide business support.
Responsibilities
Owns the processes for Inquiries, Complaints and Service Management; Responsible for monitoring metrics, regulatory trends and identifying process improvements; Development and maintenance of training materials; Partner with Medical Safety Organization to support safety initiatives, ensure alignment, etc.
Owns User roles and manages User Access Requests; Create, revise and maintain all applicable procedural documents, including WI’s and SOPs, translations; Identify, assess, and implement process improvements to the standard process.
Develop and maintain Playback Books, including detailed description of process, system architecture, validation, etc. Partner with IT and project team to maintain URS and FDS; Provides support to IT projects, including patches, new releases, etc. Works in collaboration with GCSM Project Teams to deploy new capabilities and functionalities to existing customers.
Qualifications
A minimum of 7 years of experience in Quality Systems and BA/BS Degree or equivalent, or a minimum of 5 years with advanced degree or equivalent required. A minimum of 3 years experience in a Healthcare Regulated environment required. Experience in Complaint or Service Management required. Knowledge of Complaint Management applications such as Siebel, required. Experience managing a regulated complaint solution required. Experience with at least one implementation or upgrade of a Complaint Management System required. Knowledge and expertise in quality system global regulatory requirements (such as 21CFR Part 210, 211, 610, 820, ICH Q10 and other international regulations) required.
Process design experience required. Change Management experience preferred. Demonstrated ability to interact effectively and decisively with business leaders, as well as all individual contributor and manager levels in the organization required. Strong written and verbal presentation and interpersonal skills required. Ability to make executive level presentations required. Collaborative approach and ability to connect required. Ability to operate effectively with partner I/T organizations required. Strong written and verbal presentation and interpersonal skills required. Experience facilitating groups required. Knowledge of internal controls and how they apply to application development and/or implementation of COTS products preferred. Ability to influence without authority is required. Strong collaboration and teaming skills required.
The preferred location for this position is Bridgewater, NJ; alternatively the position may be located at any MD&D site globally. Less than 25% domestic or international travel may be required.
BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI
Primary Location:North America
Other Locations:Europe/Middle East/Africa, Asia Pacific, Latin America
Organization: MD&D Global Services LLC (6209)
Job Function: Quality Systems
Description
Medical Devices & Diagnostics Global Services, LLC, a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Manager, Global Complaint and Service Management Process. The preferred location for this position is Bridgewater, NJ; alternatively the position may be located at any MD&D site globally. Less than 25% domestic and international travel may be required, based on business needs.
Medical Devices & Diagnostics Global Services, LLC., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD&D Supply Chain supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
J&J has implemented a global transformational Complaint and Service Management program that focuses on quality as a competitive advantage. It will deliver a common process, organization, and technology solution that supports medical device and diagnostic products in order to increase patient safety, meet global regulatory commitments, and improve operational efficiencies and customer satisfaction.
The Manager, GCSM is responsible for the base business aspects of the Global Complaint and Service Management System. This includes ongoing responsibility for all procedural documentation, owner of User Roles, etc. She or he ensures that appropriate metrics are defined and measured to enable monitoring and continuous improvement. Provides global leadership and guidance for the execution of processes, interpret global regulatory requirements, emerging industry trends, and apply risk management strategies. Quickly and consistently identifies opportunities that enable the organization to respond to and anticipate to regulation and emerging trends.
The Manager, GCSM is expected to have deep knowledge of the end-to-end complaint management, service, inquiry and analytics processes and platform. He or she will work independently and exhibits strong ability to collaborate with Business Partners (Franchises, IT, Market Affiliates, etc.) to provide business support.
Responsibilities
Owns the processes for Inquiries, Complaints and Service Management; Responsible for monitoring metrics, regulatory trends and identifying process improvements; Development and maintenance of training materials; Partner with Medical Safety Organization to support safety initiatives, ensure alignment, etc.
Owns User roles and manages User Access Requests; Create, revise and maintain all applicable procedural documents, including WI’s and SOPs, translations; Identify, assess, and implement process improvements to the standard process.
Develop and maintain Playback Books, including detailed description of process, system architecture, validation, etc. Partner with IT and project team to maintain URS and FDS; Provides support to IT projects, including patches, new releases, etc. Works in collaboration with GCSM Project Teams to deploy new capabilities and functionalities to existing customers.
Qualifications
A minimum of 7 years of experience in Quality Systems and BA/BS Degree or equivalent, or a minimum of 5 years with advanced degree or equivalent required. A minimum of 3 years experience in a Healthcare Regulated environment required. Experience in Complaint or Service Management required. Knowledge of Complaint Management applications such as Siebel, required. Experience managing a regulated complaint solution required. Experience with at least one implementation or upgrade of a Complaint Management System required. Knowledge and expertise in quality system global regulatory requirements (such as 21CFR Part 210, 211, 610, 820, ICH Q10 and other international regulations) required.
Process design experience required. Change Management experience preferred. Demonstrated ability to interact effectively and decisively with business leaders, as well as all individual contributor and manager levels in the organization required. Strong written and verbal presentation and interpersonal skills required. Ability to make executive level presentations required. Collaborative approach and ability to connect required. Ability to operate effectively with partner I/T organizations required. Strong written and verbal presentation and interpersonal skills required. Experience facilitating groups required. Knowledge of internal controls and how they apply to application development and/or implementation of COTS products preferred. Ability to influence without authority is required. Strong collaboration and teaming skills required.
The preferred location for this position is Bridgewater, NJ; alternatively the position may be located at any MD&D site globally. Less than 25% domestic or international travel may be required.
BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI
Primary Location:North America
Other Locations:Europe/Middle East/Africa, Asia Pacific, Latin America
Organization: MD&D Global Services LLC (6209)
Job Function: Quality Systems