- Catalent Pharma Solutions (Greendale, IN)
- …of operations, supply chain, and engineering across sites. + Ensure compliance with regulatory guidelines, industry standards, quality management systems, ... responsible for driving operational excellence, optimizing manufacturing processes, ensuring compliance with industry regulations, and fostering a culture of… more
- Lilly (Lebanon, IN)
- …constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly's ... staff. + Be a resource to the operational areas in helping them understand the regulatory requirements of their areas and programs. + Assure the site is up to date… more
- Amgen (Holly Springs, NC)
- …avoid impact to plant operations. + Ensure plant readiness and Quality and Regulatory compliance for internal and external audits related to the Mechanical/HVAC ... system owner for building mechanical systems supporting a large bio- pharmaceutical manufacturing site. Your responsibility includes HVAC and Refrigeration (HVAC/R),… more
- Lilly (Durham, NC)
- …Engineering is responsible for demonstrating leadership, teamwork, and quality and regulatory knowledge to lead the Quality Engineering team to provide guidance, ... facilities, utilities, and equipment. The position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, start up, and life… more
- Bristol Myers Squibb (Devens, MA)
- …and external stakeholders to ensure automation assay designs meet compliance and business requirements. Build effective relationships/partnerships and work ... development, IQ/OQ/PQ, and test method validation. Apply technical knowledge, regulatory requirements, and scientific principles to independently perform complex… more
- Sanofi Group (Swiftwater, PA)
- …automation computerized systems used in manufacturing processes are validated in compliance with Sanofi's quality requirements and the applicable cGMP regulations. ... Validation (CSV) lifecycle activities meet Sanofi's quality requirements and fulfil regulatory expectations. + Design and execute validation protocols and testing. +… more
- Lilly (Indianapolis, IN)
- …manufacturing facilities, external supplier organization, marketing affiliate quality operations, regulatory , research and development and other functions to educate ... on the quality system, and proactively ensure compliance of Lilly's Quality Systems with various country agency standards, industry trends and scientific principles.… more
- AbbVie (North Chicago, IL)
- …scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. + Oversees the conduct of clinical trials ... documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities. + Participation in design and execution of clinical trial… more
- Sanofi Group (Framingham, MA)
- …Manufacturing and Supply network (eg procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition ... LM GenMed. This individual provides strategic leadership, direction, and oversight for compliance and risk management programs and is responsible for fostering a… more
- Teleflex (Minneapolis, MN)
- …on-site and remote monitoring visits as well as centralized monitoring in compliance with applicable regulatory standards (FDA regulations, ICH/GCP guidelines, ... in accordance with Teleflex procedures and applicable regulations to evaluate protocol compliance , data accuracy, and subject safety by review of regulatory … more