- 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
- Cardinal Health (Indianapolis, IN)
- …clinical operations, project management, medical affairs, legal, medical writing, nonclinical, and quality teams to ensure regulatory compliance in clinical ... in accordance with regulatory agency requirements and internal standards. + ** Regulatory Compliance ** + Ensure ongoing compliance with applicable… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …for the strategic and operational activities pertaining to global and local labeling compliance and quality within Global Regulatory Affairs. + Partners ... compliance and labeling processes (labeling event management systems , RIM systems , and quality ...with good exposure to Regulatory Affairs, labeling, quality assurance, and/or compliance . + Familiarity with… 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
- 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
- J&J Family of Companies (Indianapolis, IN)
- …+ In collaboration with cross-functional team members, compile, prepare, review and submit high- quality regulatory submissions to authorities on time in US and ... regulatory input for product recalls and recall communications. + Support quality system and technical file/design dossier audits. + Maintain regulatory… 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)
- …+ Engage with external committees to develop and influence industry standards, processes and tools Regulatory and Quality Compliance : + Perform work in full ... Communication of Results and Inferences: + Assist or respond to regulatory queries working in collaboration with other statistical colleagues. Therapeutic Area… 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
- 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
- Financial Center First Credit Union (Indianapolis, IN)
- …etc. + Ensures process and system changes are in alignment with regulatory compliance requirements and risk mitigation. Helps develop process and procedures ... and Act. This position will execute company-wide credit union projects including system conversions and mergers. The ERM/ Compliance Specialist will work closely… more
- Sumitomo Pharma (Indianapolis, IN)
- …development and maintenance of a Quality Management System in full compliance with all regulatory requirements. + Ensure the development of QA systems ... regulatory expectations to ensure evolution of the Quality Management System and compliance ...+ Experience in evolving cGMP related quality systems , policies and procedures to ensure compliance … more
- Cardinal Health (Indianapolis, IN)
- …and assistance with system -based operations programs and processes to ensure compliance with State and Federal regulatory guidelines. + Oversees system ... + Provides oversight and direction for hospital pharmacy manager involvement in system quality improvement committees, assists with preparation when necessary. +… more
- Cardinal Health (Indianapolis, IN)
- …Summary** LRCGQ IT is accountable for all technology solutions for the Legal, Regulatory Compliance , Government Relations, & Quality (LRCGQ) organization. ... coding to develop, enhance and sustain the organization's software systems in a cross-functional team environment through adherence to... System (CSOS) platforms support & governance + Quality & Regulatory Affairs (QRA) technology (eg,… more
- Prime Therapeutics (Indianapolis, IN)
- …experience with understanding of Medicare, Medicaid, the Exchanges along with regulatory compliance requirements (HIPAA and/or PCI) + Experience working ... every decision we make. **Job Posting Title** IT Business Systems Analyst Sr **Job Description** The Business Systems...for serving as a key role in solving complex system problems which require the regular use of ingenuity… more
- Lilly (Lebanon, IN)
- …enable a successful startup into GMP manufacturing operations. The Associate - Computer Systems Quality Assurance is responsible for oversite of computer ... Tech@Lilly persons to develop validation strategies for the approach to computer system validation in compliance with corporate standards; consultation and… more