J&J Family of Companies
Lead, Quality Management Systems Operations
J&J Family of Companies, Providence, Rhode Island, us, 02912
J&J Family of Companies Lead, Quality Management Systems Operations in Providence, Rhode Island
Lead, Quality Management Systems Operations - 2406215524WDescriptionJohnson & Johnson is recruiting for a
Lead of Quality Management Systems (QMS) Operations ! This position can be performed remotely anywhere within the United States. Remote work may be considered on a case-by-case basis and if approved by the business.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Position Summary:Enterprise Quality is a comprehensive organization within J&J that focuses on ensuring the highest standards of quality & compliance. It encompasses a Quality Operations division that supports QMS Management and Commercial Quality Shared Services. This organization has a focus on new and innovative technologies and implementing the appropriate quality controls for the determined risk profiles.As the Lead of QMS Operations, you will have the unique opportunity to oversee the operations of Johnson & Johnson's Technology Services QMS. This role will primarily serve as the business technical lead for 2 document management systems and 1 training system. Operational support may be required for innovative analysis and support of other QMS elements such as CAPA, Document Management, Supplier Management, SDLC/Validation, and Product/Non-Product Security. Your role will be critical in ensuring that the QMS is flawless, world-class, and adheres to GxP requirements and ISO regulations while consistently implementing continuous enhancements.Key ResponsibilitiesFunction as a Business Super User for the Document Management and Learning Management systems. Support other administrators with ongoing support, training, and activities for their responsible area.Responsible for business problem resolution of document management and/or training workflows and enhancements.Delivers business system maintenance in support of the health and efficiency of the system.Responsible to support the Document Management and Training process owner as needed.Develops key quality metrics from customer experiences. Analyzes results and develops a plan for improvement.Acts as a 'change agent' in preparation for system enhancements to create smooth transitions for administrators and users of the systems.Supports Health authority or agency inspections when required.Provide an environment that encourages the company’s credo and the value of a diverse workforce.QualificationsAbility to partner with others and create business relationships.Strong cross-boundary collaboration, interdependent partnering, and influence skills.Able to inspire trust and quickly build credibility.Excellent listening skills and incorporates diverse points of view.Strong level of innovative thinking and trend spotting.Problem-solving skills to assist in maintaining project progress and on design issues.Strong intellect, big picture thinking ability, complemented by operational and business planning orientation.Sets clear performance standards and drives to results.Works effectively in a virtual team environment.Strong analytical and strategic skills with a bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high-level, and detailed.Experience and Skills:Education:A Bachelor’s or equivalent University degree & OR 6 years relevant experience is required. A focus in Computer Science, Engineering, Information Systems, Business Administration, or other related field preferred.Required:Experience as a business administrator for training and/or document management.Experience in quality assurance, compliance, and quality systems.Experience in identifying areas of potential compliance risks and implementing strategies to reduce those risks.Experience with Life Science policies, procedures, work instructions, forms, and templates.Experience with different forms of adult learning techniques.Understanding of a Quality Management System.Understanding of Global and Regional GxP Regulations.Preferred:Experience working with Veeva and/or Documentum software.Experience working with ComplianceWire and/or CSOD software.Experience building on Microsoft Powerapps or similar platforms.Experience with data analytics tools such as Tableau, Qlik, etc.Experience with Six Sigma/Process Excellence tools, training, and certification.Other:This position can be performed remotely.The anticipated base pay range for this position is $91,000-147,000 USD.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Primary Location : NA-US-New Jersey-RaritanOther Locations : North AmericaOrganization : Johnson & Johnson Services Inc. (6090)
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Lead, Quality Management Systems Operations - 2406215524WDescriptionJohnson & Johnson is recruiting for a
Lead of Quality Management Systems (QMS) Operations ! This position can be performed remotely anywhere within the United States. Remote work may be considered on a case-by-case basis and if approved by the business.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Position Summary:Enterprise Quality is a comprehensive organization within J&J that focuses on ensuring the highest standards of quality & compliance. It encompasses a Quality Operations division that supports QMS Management and Commercial Quality Shared Services. This organization has a focus on new and innovative technologies and implementing the appropriate quality controls for the determined risk profiles.As the Lead of QMS Operations, you will have the unique opportunity to oversee the operations of Johnson & Johnson's Technology Services QMS. This role will primarily serve as the business technical lead for 2 document management systems and 1 training system. Operational support may be required for innovative analysis and support of other QMS elements such as CAPA, Document Management, Supplier Management, SDLC/Validation, and Product/Non-Product Security. Your role will be critical in ensuring that the QMS is flawless, world-class, and adheres to GxP requirements and ISO regulations while consistently implementing continuous enhancements.Key ResponsibilitiesFunction as a Business Super User for the Document Management and Learning Management systems. Support other administrators with ongoing support, training, and activities for their responsible area.Responsible for business problem resolution of document management and/or training workflows and enhancements.Delivers business system maintenance in support of the health and efficiency of the system.Responsible to support the Document Management and Training process owner as needed.Develops key quality metrics from customer experiences. Analyzes results and develops a plan for improvement.Acts as a 'change agent' in preparation for system enhancements to create smooth transitions for administrators and users of the systems.Supports Health authority or agency inspections when required.Provide an environment that encourages the company’s credo and the value of a diverse workforce.QualificationsAbility to partner with others and create business relationships.Strong cross-boundary collaboration, interdependent partnering, and influence skills.Able to inspire trust and quickly build credibility.Excellent listening skills and incorporates diverse points of view.Strong level of innovative thinking and trend spotting.Problem-solving skills to assist in maintaining project progress and on design issues.Strong intellect, big picture thinking ability, complemented by operational and business planning orientation.Sets clear performance standards and drives to results.Works effectively in a virtual team environment.Strong analytical and strategic skills with a bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high-level, and detailed.Experience and Skills:Education:A Bachelor’s or equivalent University degree & OR 6 years relevant experience is required. A focus in Computer Science, Engineering, Information Systems, Business Administration, or other related field preferred.Required:Experience as a business administrator for training and/or document management.Experience in quality assurance, compliance, and quality systems.Experience in identifying areas of potential compliance risks and implementing strategies to reduce those risks.Experience with Life Science policies, procedures, work instructions, forms, and templates.Experience with different forms of adult learning techniques.Understanding of a Quality Management System.Understanding of Global and Regional GxP Regulations.Preferred:Experience working with Veeva and/or Documentum software.Experience working with ComplianceWire and/or CSOD software.Experience building on Microsoft Powerapps or similar platforms.Experience with data analytics tools such as Tableau, Qlik, etc.Experience with Six Sigma/Process Excellence tools, training, and certification.Other:This position can be performed remotely.The anticipated base pay range for this position is $91,000-147,000 USD.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Primary Location : NA-US-New Jersey-RaritanOther Locations : North AmericaOrganization : Johnson & Johnson Services Inc. (6090)
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