Full job description Job Overview Post Date
May 15, 2024
Number
ICIMS-********
Job Function
QA&RA
Location
Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States
Country
United States
Shift
1st
About the Position Overview Werfen
Werfen 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 Summary Reporting 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 Accountabilities Development of al 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 stakeholders 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 relationships Corporate QA/RA Team Digital Board QA/RA Team IT Leads and teams Global Systems Analyst QA/RA leadership at Werfen Technology Centers and teams Key stakeholders across the organization Qualifications Minimum Knowledge & Experience required for the position: Bachelor's degree preferably in STEM, Information Systems, or Business Minimum of 5 years of directly related experience with implementing and maintaining enterprise eQMS platforms. Minimum of 5 years of directly related experience with QMS Additional Skills/Knowledge: IT Systems Project Management Language: English (fluent), Spanish (basic)
Skills & Capabilities: Well-developed leadership skills Strong verbal and written communication skills. Ability to present complex information in an easily consumable manner Ability to build relationships within Werfen departments Work cross-functionally to understand business needs and provide actionable insights for ongoing stakeholders needs Robust organizational skills Excellent time management skills with proven ability to meet deadlines Strong analytical and problem-solving skills Advanced understanding of database construction and configuration Good computer skills and proficiency with QA/RA systems Ability to effectively champion the project to completion through constant interaction with peers and senior leadership in a professional manner Ability to evaluate issues and new requirements to assess impact to the product and/or business Ability to accept and act on constructive criticism Demonstrates negotiation skills for conflict resolution Be a high energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people. Travel requirements: 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 for assistance.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.
