- Sumitomo Pharma (Indianapolis, IN)
- …a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the Senior Manager ... Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment Registrations, Drug Product Listings). +… more
- Grifols Shared Services North America, Inc (Hammond, IN)
- …and initiatives that significantly impact the business. + Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
- Wolters Kluwer (Indianapolis, IN)
- **Lead Technology Product Manager ** - Commercial Drug Information This role follows a hybrid model, offering the flexibility to work remotely while staying ... **SUMMARY** As part of the **Wolters Kluwer Health team** , the **Lead Technology Product Manager for Medi-Span** plays a critical role in advancing our… more
- Trane Technologies (Noblesville, IN)
- …performance of the plant quality team and ensures quality assurance activities, including product and customer regulatory audits, final product test and ... go. **Job Summary:** Trane Technologies is hiring a Sr. Manager - Plant Quality in Noblesville, Indiana. The Sr....and separate Quality Management System (QMS) as defined by ISO/ FDA certifications comprised of a medical device ISO13485/MDR plant… more
- Kerry (Evansville, IN)
- …products released are compliant and safe foods. Support the site for regulatory inspections ( FDA /CFIA), identify preserved (ie.organic, Kosher) and customer ... to produce safe quality food, acting as SQF Practitioner or equivalent GFSI manager (BRC, FSSC 22000). + Quality Systems: Support food safety and quality systems… more
- Bristol Myers Squibb (Indianapolis, IN)
- …rest-of-world cGMP regulations and guidance. . Knowledge and proven experience in FDA , EMA, or other regulatory authority. . Demonstrated leadership, ... RayzeBio aims to be the global leader in radiopharmaceuticals. **Summary** The Senior Manager , QA for QC is responsible for quality oversight of the Quality Control… more
- Novo Nordisk (Bloomington, IN)
- …integrity and ensure compliance with company SOP's, specifications, as well as cGMP, ICH, FDA , EMA regulations or guidelines + Leads regulatory and client audits ... from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility… more
- Novo Nordisk (Bloomington, IN)
- …from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility ... Nordisk and help us make what matters. Primary - Drug Product Primary Manufacturing produces sterile pharmaceuticals. The department includes equipment preparation,… more
- Novo Nordisk (Bloomington, IN)
- …quality assurance functions. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal ... from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility… more
- Kelly Services (Plainfield, IN)
- …continuous improvement. **Key Responsibilities:** + Implement and enhance the QMS following regulatory requirements (ISO, FDA , EPA). + Manage audit programs and ... **Kelly Science & Clinical has a new, permanent opportunity for a Quality Manager in Plainfield, IN!** **Shift:** M-F | 8am-5pm **A Direct Hire Opportunity**… more