Werfenlife SA.
Global QA/RA Systems Manager
Werfenlife SA., Bedford, Texas, United States, 76022
Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United StatesCountryUnited StatesShift1stAbout the Position
Overview
WerfenWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.Job SummaryReporting to the Corporate VP QA/RA, the Global QA/RA Systems Manager is responsible for providing leadership, planning, project coordination, and management to develop a cost-effective electronic Quality Management Systems (eQMS) and harmonized QA/RA information systems while concurrently facilitating efficient operations to meet current and future business needs. Responsible for collaborating with QA/RA partners within Werfen Technology Centers and various departments (e.g., IT) and outside vendors to develop efficient and effective processes and workflows as well as analyzing and directing all functionally related activities within the scope of the eQMS. This position is accountable for ensuring continuity and successful delivery of functional services to users throughout the organization.Responsibilities
Key AccountabilitiesDevelopment of a global strategy, implementation, maintenance, operations, and optimization of the overall eQMS platforms.Leverage synergies between processes and workflows in the different Technology Centers and promote standardization/harmonization to the extent possible.Lead the Digital Board QARA meetings from the QA/RA side.Conduct and participate in the analysis of workflows and design of functionality and/or improvements to systems, ensuring both process and system requirements are fully identified, evaluated, tested, and implemented.Identify opportunities for process improvement, automation, application operational efficiency, and security.Identify and troubleshoot system issues and work with others (IT, partners, vendors) as needed to bring to resolution.Work cross-functionally to understand business needs and provide actionable insights for ongoing stakeholder needs.Work with leadership at various Werfen technology centers to ensure timely implementation and delivery of new functionality and enhancements.Work with stakeholders within QARA at Werfen Technology Centers to create, update and oversee processes and workflows for eQMS systems and implement timely updates as changes occur.Assist with data analytics and reporting capabilities, ensuring systems are optimized to reduce manual reporting.Drive definition of business rules for platform governance, processes and procedures.Manage the eQMS supplier relationships.Create and execute a strategy to ensure that local eQMS stakeholders are trained.Networking/Key relationshipsCorporate QA/RA TeamDigital Board QA/RA TeamIT Leads and teamsGlobal Systems AnalystQA/RA leadership at Werfen Technology Centers and teamsKey stakeholders across the organizationQualifications
Minimum Knowledge & Experience required for the position:Bachelor’s degree preferably in STEM, Information Systems, or BusinessMinimum of 5 years of directly related experience with implementing and maintaining enterprise eQMS platforms.Minimum of 5 years of directly related experience with QMSAdditional Skills/Knowledge:
IT Systems Project ManagementLanguage: English (fluent), Spanish (basic)
Skills & Capabilities:Well-developed leadership skillsStrong verbal and written communication skills. Ability to present complex information in an easily consumable mannerAbility to build relationships within Werfen departmentsWork cross-functionally to understand business needs and provide actionable insights for ongoing stakeholder needsRobust organizational skillsExcellent time management skills with proven ability to meet deadlinesStrong analytical and problem-solving skillsAdvanced understanding of database construction and configurationGood computer skills and proficiency with QA/RA systemsAbility to effectively champion the project to completion through constant interaction with peers and senior leadership in a professional mannerAbility to evaluate issues and new requirements to assess impact to the product and/or businessAbility to accept and act on constructive criticismDemonstrates negotiation skills for conflict resolutionBe a high energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people.Up to 25% travel, domestic and international.Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.
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Overview
WerfenWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.Job SummaryReporting to the Corporate VP QA/RA, the Global QA/RA Systems Manager is responsible for providing leadership, planning, project coordination, and management to develop a cost-effective electronic Quality Management Systems (eQMS) and harmonized QA/RA information systems while concurrently facilitating efficient operations to meet current and future business needs. Responsible for collaborating with QA/RA partners within Werfen Technology Centers and various departments (e.g., IT) and outside vendors to develop efficient and effective processes and workflows as well as analyzing and directing all functionally related activities within the scope of the eQMS. This position is accountable for ensuring continuity and successful delivery of functional services to users throughout the organization.Responsibilities
Key AccountabilitiesDevelopment of a global strategy, implementation, maintenance, operations, and optimization of the overall eQMS platforms.Leverage synergies between processes and workflows in the different Technology Centers and promote standardization/harmonization to the extent possible.Lead the Digital Board QARA meetings from the QA/RA side.Conduct and participate in the analysis of workflows and design of functionality and/or improvements to systems, ensuring both process and system requirements are fully identified, evaluated, tested, and implemented.Identify opportunities for process improvement, automation, application operational efficiency, and security.Identify and troubleshoot system issues and work with others (IT, partners, vendors) as needed to bring to resolution.Work cross-functionally to understand business needs and provide actionable insights for ongoing stakeholder needs.Work with leadership at various Werfen technology centers to ensure timely implementation and delivery of new functionality and enhancements.Work with stakeholders within QARA at Werfen Technology Centers to create, update and oversee processes and workflows for eQMS systems and implement timely updates as changes occur.Assist with data analytics and reporting capabilities, ensuring systems are optimized to reduce manual reporting.Drive definition of business rules for platform governance, processes and procedures.Manage the eQMS supplier relationships.Create and execute a strategy to ensure that local eQMS stakeholders are trained.Networking/Key relationshipsCorporate QA/RA TeamDigital Board QA/RA TeamIT Leads and teamsGlobal Systems AnalystQA/RA leadership at Werfen Technology Centers and teamsKey stakeholders across the organizationQualifications
Minimum Knowledge & Experience required for the position:Bachelor’s degree preferably in STEM, Information Systems, or BusinessMinimum of 5 years of directly related experience with implementing and maintaining enterprise eQMS platforms.Minimum of 5 years of directly related experience with QMSAdditional Skills/Knowledge:
IT Systems Project ManagementLanguage: English (fluent), Spanish (basic)
Skills & Capabilities:Well-developed leadership skillsStrong verbal and written communication skills. Ability to present complex information in an easily consumable mannerAbility to build relationships within Werfen departmentsWork cross-functionally to understand business needs and provide actionable insights for ongoing stakeholder needsRobust organizational skillsExcellent time management skills with proven ability to meet deadlinesStrong analytical and problem-solving skillsAdvanced understanding of database construction and configurationGood computer skills and proficiency with QA/RA systemsAbility to effectively champion the project to completion through constant interaction with peers and senior leadership in a professional mannerAbility to evaluate issues and new requirements to assess impact to the product and/or businessAbility to accept and act on constructive criticismDemonstrates negotiation skills for conflict resolutionBe a high energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people.Up to 25% travel, domestic and international.Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.
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