- Abbott (Westfield, IN)
- …Our 114,000 colleagues serve people in more than 160 countries. ** Quality System & Regulatory Compliance Manager** **Working at Abbott** At Abbott, ... leadership in quality and regulatory compliance matters. The Quality System ...Manage all phases of external audits. + Serve as Quality Systems Subject Matter Expert and Generalist/Escort.… more
- Lilly (Indianapolis, IN)
- …is part of the Lilly Pharmaceutical Delivery Systems (PDS) Quality Systems and Regulatory Compliance Team. The team provides support and oversight ... Management System to ensure on-going management of quality system requirements in order to maintain compliance and drive continuous improvement… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …+ 8+ years of experience in the pharmaceutical industry, with 6+ years in Regulatory Affairs, quality assurance/ compliance , or research and development. + ... will contribute:** + Provides operational oversight to the activities related to regulatory information management data and system maintenance, guiding the team… more
- Lilly (Indianapolis, IN)
- …Bachelor Degree + Minimum of 5 years of experience in Supply Chain, Finance, FDA/ Regulatory Affairs, Quality or trade compliance experience + Qualified ... We keep our finger on the pulse of trade compliance , providing prompt updates on regulatory changes...in FTZ management. + Experience with automated FTZ management systems . + Proficiency in navigating SAP + Have the… more
- Fresenius Medical Center (Carmel, IN)
- …ensuring appropriate actions taken to ensure required resolution. Demonstrates pride in the quality of work, regulatory compliance , and the environmental ... vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and FMS policy requirements.… more
- Lilly (Indianapolis, IN)
- …working on long-term technology solutions, leading and supporting efforts to drive optimization, regulatory and Quality compliance , and reliability of unit ... to drive understanding and knowledge of large scale SDD systems . + Collaborate with manufacturing sites to solve current...the development and use of control strategies, unit operations, Quality and regulatory compliance and… more
- Fujifilm (Indianapolis, IN)
- …on schedule. + Completion of provided trainings. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures ... similar resources on existing products. + Learn and remain compliant with all regulatory and quality requirements. + Occasionally participates in customer site… more
- Fujifilm (Indianapolis, IN)
- …the business, to work on customer systems . + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that ... handles other duties as assigned. + Monitors TAC phone system wall boards to ensure that proper statuses are...US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Eliassen Group (Indianapolis, IN)
- …triage and troubleshooting. + Develop business processes and solutions to ensure quality , cost-effectiveness, and regulatory compliance . + Coordinate with ... **Business System Analyst** **Anywhere** **Type:** Contract **Category:** Business Analysis...to meet business goals. + Work in phases of systems analysis, considering the business implications of technology applications.… more
- Edwards Lifesciences (Indianapolis, IN)
- …clinical project management, field monitoring, and/or clinical research coordination) including quality assurance/control and regulatory compliance or field ... and 510(k) + Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System ), eTMF (electronic Trial Master… more
- Lilly (Indianapolis, IN)
- …management support and expertise to LPS to ensure adherence to US Legal, Privacy, Quality , Ethics & Compliance , and Regulatory requirements pertaining to ... and pharmaceutical environment, trends in legal and privacy requirements, innovation in quality systems , and best-in-class customer engagements + Operate in a… more
- Lilly (Indianapolis, IN)
- …of tools and systems , where applicable and stay informed of technological advances. ** Regulatory and Quality Compliance :** + Perform work in full ... statistical analysis plans, write reports and communicate results, assist/respond to regulatory queries. + Assist in and/or be accountable for selecting statistical… more
- Prime Therapeutics (Indianapolis, IN)
- …Office Suite **Preferred Qualifications** + Health insurance/PBM operations and/or regulatory compliance audit experience + Project management experience + ... + Perform quality reviews and analysis of audit deliverables to ensure compliance with contractual and regulatory requirements. + Other duties as assigned … more
- System One (Indianapolis, IN)
- …seamless project integration. + Review the installation of designed equipment and systems to ensure compliance with construction documents and industry ... Electrical Engineer - Building Systems Candidates can work in Indianapolis or South...get work done more efficiently and economically, without compromising quality . System One not only serves as… more
- Lilly (Indianapolis, IN)
- …electronic Document Management System (eDMS) and is part of the Global Quality Systems (GQS) organization. The Advisor - QA, Global Quality ... (QualityDocs) is operating in compliance with regulations and Lilly Global Quality System standards. **Key Objectives/Deliverables:** The QA Advisor, Global … more
- Lilly (Indianapolis, IN)
- …Global Quality System improvements. + Closely partner with Global Quality Compliance (GQC) External Monitoring process by being continually aware of ... to make life better for people around the world. The Sr Director - Global Quality Systems (GQS)- Advanced Therapy Medicinal Products - (ATMP) role will support… more
- Lilly (Indianapolis, IN)
- …across Lilly Legal and in other Lilly functional areas (ie, marketing, medical, regulatory , compliance , quality etc.) and establish trust and credibility ... protocols, processes, and procedures, incorporating evolving litigation best practices in compliance with all applicable laws, regulations and internal policies. +… more
- Bristol Myers Squibb (Indianapolis, IN)
- …radiopharma experience is highly valued but not required. + Demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech ... policies and procedures related to all aspects of computer system validation and applicable local processes and policies. +...+ Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems … more
- City National Bank (Indianapolis, IN)
- …The Business Systems Analyst Supervisor oversees development, maintenance, training, regulatory compliance , and system support for Residential Lending, ... escalated system support to identify and resolve system issues, maintaining systems developed or installed,...to make recommendations for improving or further leveraging these systems . * Performs in-depth user and quality … more
- Prime Therapeutics (Indianapolis, IN)
- …GED is required + 8 years of work experience in Healthcare, PBM, Operations, Regulatory Compliance Business Analysis and/or Project Management + 5 years of ... + Previous experience developing and overseeing Business Analysis, Project Management, System Development, Training and/or Quality Programs **Physical Demands**… more