- 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