- Highmark Health (Indianapolis, IN)
- …team of specialists. Identify, develop, coordinate, and implement legislative, regulatory , sub- regulatory , and licensing / accreditation requirements.Perform ... ongoing monitoring and analysis of external regulatory and industry intelligence, collaborating with impacted stakeholders, and providing regular, executive… more
- Novo Nordisk (Bloomington, IN)
- …all levels and in a wide range of different work groups including senior leadership and regulatory agencies + Strong analytical and problem-solving abilities. ... records (eg deviations change controls, etc.) to ensure compliance to regulatory and procedural requirements is maintained + Process supplier complaint investigation… more
- Novo Nordisk (Bloomington, IN)
- …of client regulatory submissions + Monitors and assesses changes to regulatory guidance and compendial monographs + Supports and enhances effectiveness of ... in a wide range of different work groups including senior leadership and regulatory agencies + Strong...+ Edits Standard Operating Procedures (SOPs) and reports with guidance from supervisor + Seeks best practices for daily… more
- Lilly (Indianapolis, IN)
- …external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance , current expectations and business needs. This role also aids ... world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity...the other sites. + Benchmark industry trends and emerging regulatory guidance / requirements in the field… more
- Lilly (Indianapolis, IN)
- …feedback, coaching, mentoring to the personnel on the interpretation of corporate and regulatory GMP requirements (GQS) related to sterility assurance and micro ... Assurance within DPEM and CMs upon request. + Responsible for Sterility Assurance review at CM. + Ensure continuous regulatory and technology oversight. +… more
- Lilly (Indianapolis, IN)
- …as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance and current expectations, as well as align with business ... of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Product Network (PPN). This… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages ... as needed. + Assures submissions are compliant with relevant regulations and guidance . + Provides regulatory sciences leadership, decision making, guidance… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Lilly (Indianapolis, IN)
- …Program Owner will collaborate with site inspection readiness teams and provide guidance to lead investigators, functional leaders, and senior quality ... to make life better for people around the world. **Advisor, Quality Assurance - Change and Deviation Program Owner, Global API Network Expansion**… more
- Republic Airways (Indianapolis, IN)
- …**POSITION PURPOSE** The Senior QA Automation Lead oversees the quality assurance function for Republic Airways leading a team of QA engineers to ensure ... Mentorship:** + Lead and mentor a team of QA engineers, providing guidance , technical support, and career development opportunities. + Assign tasks effectively,… more
- Novo Nordisk (Bloomington, IN)
- …Cross-Functional Collaboration: + Collaborate effectively with Research & Development, Quality Assurance , Regulatory Affairs, and Production teams to align ... Nordisk and help us make what matters. As a Senior Aseptic Manufacturing Process Engineer at Novo Nordisk, you...development. + Technical Expertise and Mentorship: + Provide expert guidance on aseptic techniques, regulatory frameworks, and… more
- Lumen (Indianapolis, IN)
- …manager to bolster and drive our compliance programs. Reporting to the Senior Director Security for GRC and Business Enablement, the information Security Governance ... our external and internal obligations. This role will be expected to provide guidance and make determinations relevant on controls that govern the steps, methods, or… more
- State of Indiana (Indianapolis, IN)
- Senior Environmental Manager Date Posted: May 16, 2025 Requisition ID: 460316 Location: Indianapolis, IN, US, 46204 Work for Indiana Begin a fulfilling career with ... the Indiana Department of Environmental Management. This employee serves as a senior project manager responsible for managing and reviewing Resource Conservation and… more
- Prime Therapeutics (Indianapolis, IN)
- …It fuels our passion and drives every decision we make. **Job Posting Title** Senior Internal Auditor - Remote **Job Description** The Senior Internal Auditor ... fostering strong cross-functional relationships and delivering risk-based insights, the Senior Internal Auditor helps drive informed decision-making and support… more
- Edwards Lifesciences (Indianapolis, IN)
- …with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize ... and be part of our inspiring journey. As the ** Senior Specialist, Commercial Clinical Imaging** , you will be...and other imaging modality acquisition and interpretation and provide guidance on case planning strategy execution. + Responsible for… more
- Cardinal Health (Indianapolis, IN)
- …on those requirements. + Uphold quality standards that adhere to company, regulatory , and HIPAA policies and procedures. + Collaborate across various functions, ... skills with a proven ability to develop and execute effective quality assurance programs. + Works independently within established procedures; may receive general … more
- Novo Nordisk (Bloomington, IN)
- …of client regulatory submissions + Monitors and assesses changes to regulatory guidance and compendial monographs + Supports and enhances effectiveness of ... Nordisk and help us make what matters. The Quality Assurance department is responsible for all aspects of the...in a wide range of different work groups including senior leadership and regulatory agencies + Strong… more
- Bausch + Lomb (Indianapolis, IN)
- …B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance , Pharmacovigilance/GPSS and Drug/Device ... completion of clinical studies according to applicable regulations and guidance , ICH and GCP, and Bausch & Lomb SOPs...are being met and provide the operations director and/or senior management with timely updates on progress and changes… more
- Cook Medical (Bloomington, IN)
- …include (but are not limited to) product/process remediation, risk analysis, regulatory approval support, and product/process improvements. The Senior Engineer ... Overview Senior Engineer, Sustaining, will perform activities related to...and with other functional personnel (Production Engineering, Product Management, Regulatory , Clinical, Quality Engineering, Quality Assurance , Operations,… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... complements that of the Global Quality function. The leader shall provide guidance , strategic direction, and leadership to the Global Quality function with… more