- 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
- Cardinal Health (Indianapolis, IN)
- …procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements ... services are properly reviewed for quality and documented. **_Job Summary_** The Senior Specialist, Quality Assurance executes quality programs, policies, and… 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
- Sallie Mae (Indianapolis, IN)
- …This role will develop and implement robust processes, policies, and quality assurance tools that uphold regulatory standards, mitigate operational risk, and ... and escalation protocols. + Establish and monitor key risk indicators (KRIs), quality assurance metrics, and governance reporting to senior leadership. + Conduct… 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
- Ricoh Americas Corporation (Indianapolis, IN)
- ** Senior Engineer, Clinical** POSITION PROFILE The Senior Engineer, Clinical is a position which interacts with physician customers, biomedical engineers, and ... from DICOM segmentation, STL file optimization, 3D printing, quality assurance , delivery of the 3D printed model to the...and other paperwork as necessary. + Complies with all regulatory and production requirements and escalates any quality /… 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
- 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
- Prime Therapeutics (Indianapolis, IN)
- …Enterprise Architect - Cloud Transformation - Remote **Job Description** The Senior Principal Architect is responsible for initiating and leading strategic solutions ... and information), shared infrastructure services and shared application services. The Senior Principal Architect leads the analysis and design tasks to support… more
- GE Aerospace (Indianapolis, IN)
- …practices and procedures. Activities require professional judgment but may need more senior levels of guidance . + Provide concise, complete, and accurate ... issues related to NTI/NPI projects. + Oversee both Supplier Quality Assurance and Supplier Quality Development, including supplier qualifications, action plans,… more
- GE Aerospace (Indianapolis, IN)
- …practices and procedures. Activities require professional judgment but may require more senior levels of guidance . + Provide concise, complete, and accurate ... coach/mentor all deliverables of APQP. + Includes both Supplier Quality Assurance and Supplier Quality Development. Includes supplier qualifications, action plans,… more
- Prime Therapeutics (Indianapolis, IN)
- …decision we make. **Job Posting Title** MTM Specialist Sr **Job Description** The Senior Medication Therapy Management (MTM) Service Specialist will act as a Subject ... of the MTM programs in addition to assisting the leaders with Quality Assurance , training and daily tasks as needed. **Responsibilities** + Receive inbound and make… more
- Evolent (Indianapolis, IN)
- …decision-making. + Act as a key resource for Initial Clinical Reviewers, offering guidance and expertise to ensure the application of best practices. + Provides ... with requesting physicians or ordering providers, when available, within the regulatory timeframe of the request. + Utilizes medical/clinical review guidelines and… more