Manager Quality Training Change Mgmt at Johnson & Johnson in Titusville, NJ
The Manager, Process, Document & Quality Management leads all aspects of the development and maintenance of processesassociated with the Copy Approval Process. This role serves as the Subject Matter Authority for Document Control within Promotional Review and includes creation/management of department Quality record (CAPA Champion) including procedural document development, implementation, training, periodic reviews, revisions and obsolescence of documents, impact assessment process management, and contribution of training contents to ensure consistency with the procedural documents. In addition, this role ensures quality and compliance to processes, including identification, and resolution to Compliance issues, vigilance for self-identified process improvement opportunities, providing communications /awareness to company and compliance guidelines, and ensure timely completion of quality records as the and external Audit Lead. Document, Quality Management & Quality Assurance (50% of role) Audit Lead for /external audit to develop, handle, maintain, and monitor all PRD Controlled Documents (e.g., SOP, WI, Job Aid) including action plans for resolution of identified issues and avoiding and/or mitigating future quality issues. Serve as the JSA Corrective Action/Preventative Action (CAPA) Champion for PRD, providing Quality System support, oversight and/or responsibility for timely closure/documentation of Quality Event Management records and the PRD Lead for all Quality-related projects and/or vendors (e.g., Baldwin & Obenauf) Monitors and ensures appropriate use of policies, processes and procedures including development/implementation of corrective action and resolution of problematic issues. Thereafter, provides general framework on how to avoid similar situations in the future Conduct periodic monitoring of PRS Leader records; perform monitoring assessments and proactively work with Associate Directors toto and/or mitigate any non-conformance issues actual or potential. In partnership with PRD Training Manager, ensure that all project elements under development follow and align to departmental SOPs; including documentation of curriculum content, work instructions, training, and notices and accurately stored and tagged for easy search & distribution. Actively participate in system and process validation and testing for all configuration additions or changes. CAPA Champion Lead in achieving Quality Assurance results. Training and Organizational Change Support In collaboration with PRD Leadership and Training Manager assist with:
Development, improvement, implementation, and tracking of organizational change projects in alignment with copy approval standard operating procedures, policies, service level agreements, goals, and objectives. Proactively identify training needs of /external partners for the departement adult learning along with organizational change philosophies and practice. Lead, and conduct training sessions for end users including crafting and maintaining training resources including curriculum development to capitalize on differentiated user experience and learning needs to ensure all partners remain current with process and system knowledge and capabilities. Demonstrate and understand the appropriate learning tools and construct through a variety of mediums (hands-on, live, WebEx etc.) Identify, build, and distribute various communications such as system improvements, functionality changes, process updates/advancements, standard methodologies, and training resources Identify/implement and optimize departmental structure to coordinate and curate training resources and communications for end user accessibility and traceability including ensuring the appropriateness of training content and resources to align with changes to SOPs, policies, and other related Work Instructions Assist Associate Director, Innovation, Training and Communication with the creation and dissemination of VOC surveys; identification of insights, trends and training needs to implement appropriate action At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. Qualifications Requirements Bachelors Degree is essential 5-10 Year Experience in Document Quality Assurance, Writing and Interpreting SOP within Pharma/Healthcare Compliance Sector Thorough project management principles and application to fully manage implementation based on full understanding of business processes, system capabilities and priorities Develop project plans and lead a project from inception to implementation. Must be able to prioritize and manage multiple projects. Ability to collaborate and work in a matrixed organization supporting multiple stakeholders Excellent verbal, written and presentation skills with ability to write communications for a variety of audiences. Build strong partnerships with all levels across the organization, as well as to interact effectively with senior management. Understanding of regulatory and health care compliance guidelines with regards to process and system technology. Think strategically about technology and business processes and determine new solutions to improve overall efficiency. Cross functional team experience highly desired Comprehensive understanding of compliant business practices Cross functional team experience highly desired Comprehensive knowledge of compliant business practices and vendor management Ability to collaborate and work in a matrixed organization supporting multiple stakeholders Organizational and time management skills Strong computer skills a must (i.e., Excel, Access, Word, PowerPoint) Problem solving/resolution and Cross functional influencing skills Must be customer focused, goal driven and a problem-solver Exceptional Project Management skills Exceptional communication skills, both verbal and written and confidence in presenting to broad audiences Analytical mind-set to interpret data and experiences to offer solution-based strategies Able to work well in a fast-paced environment Appropriately influence without formal authority Must be detail-oriented Must be team player, goal driven and a problem-solver Primary Location United States-New Jersey-Titusville-1125 Trenton Harbourton Road Organization Janssen Scientific Affairs, LLC (6120) Job Function Quality Requisition ID 2206005479W
Salary Range:
$80K -- $100K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Development, improvement, implementation, and tracking of organizational change projects in alignment with copy approval standard operating procedures, policies, service level agreements, goals, and objectives. Proactively identify training needs of /external partners for the departement adult learning along with organizational change philosophies and practice. Lead, and conduct training sessions for end users including crafting and maintaining training resources including curriculum development to capitalize on differentiated user experience and learning needs to ensure all partners remain current with process and system knowledge and capabilities. Demonstrate and understand the appropriate learning tools and construct through a variety of mediums (hands-on, live, WebEx etc.) Identify, build, and distribute various communications such as system improvements, functionality changes, process updates/advancements, standard methodologies, and training resources Identify/implement and optimize departmental structure to coordinate and curate training resources and communications for end user accessibility and traceability including ensuring the appropriateness of training content and resources to align with changes to SOPs, policies, and other related Work Instructions Assist Associate Director, Innovation, Training and Communication with the creation and dissemination of VOC surveys; identification of insights, trends and training needs to implement appropriate action At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. Qualifications Requirements Bachelors Degree is essential 5-10 Year Experience in Document Quality Assurance, Writing and Interpreting SOP within Pharma/Healthcare Compliance Sector Thorough project management principles and application to fully manage implementation based on full understanding of business processes, system capabilities and priorities Develop project plans and lead a project from inception to implementation. Must be able to prioritize and manage multiple projects. Ability to collaborate and work in a matrixed organization supporting multiple stakeholders Excellent verbal, written and presentation skills with ability to write communications for a variety of audiences. Build strong partnerships with all levels across the organization, as well as to interact effectively with senior management. Understanding of regulatory and health care compliance guidelines with regards to process and system technology. Think strategically about technology and business processes and determine new solutions to improve overall efficiency. Cross functional team experience highly desired Comprehensive understanding of compliant business practices Cross functional team experience highly desired Comprehensive knowledge of compliant business practices and vendor management Ability to collaborate and work in a matrixed organization supporting multiple stakeholders Organizational and time management skills Strong computer skills a must (i.e., Excel, Access, Word, PowerPoint) Problem solving/resolution and Cross functional influencing skills Must be customer focused, goal driven and a problem-solver Exceptional Project Management skills Exceptional communication skills, both verbal and written and confidence in presenting to broad audiences Analytical mind-set to interpret data and experiences to offer solution-based strategies Able to work well in a fast-paced environment Appropriately influence without formal authority Must be detail-oriented Must be team player, goal driven and a problem-solver Primary Location United States-New Jersey-Titusville-1125 Trenton Harbourton Road Organization Janssen Scientific Affairs, LLC (6120) Job Function Quality Requisition ID 2206005479W
Salary Range:
$80K -- $100K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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