- 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
- Stryker (Fort Wayne, IN)
- …and regulatory compliance, drive actions on findings, and partner with Regulatory Affairs to meet global compliance requirements ( FDA , EU, EMEA, APAC). ... **Stryker** is hiring a **Quality Manager , Software Design Assurance** to manage a team...both internal and external audits, including direct interaction with regulatory agencies such as the FDA , MoH,… more
- Lundbeck (Fort Wayne, IN)
- …Account Manager , you lead the promotion of our infusion product , driving demand creation by providing comprehensive clinical knowledge, executing sales and ... BioPharmaceutical Account Manager - Fort Wayne, IN Requisition ID: 6708...regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical… more
- Ricoh Americas Corporation (Indianapolis, IN)
- …equipment requirements, and to acquire and maintain the equipment necessary to validate product quality. + Ensures compliance with FDA , HIPAA, and other ... MANAGER I, QUALITY, ADDITIVE MANUFACTURING POSITION PROFILE The...registrar/notified bodies with support from Director level Quality & Regulatory personnel. Job Duties and Responsibilities **Quality System Development… 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
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