- Catalent Pharma Solutions (Kansas City, MO)
- …department remains engaged and motivated; + Analyze, resolve, or assist in solving compliance and customer issues; + Ensure regulatory and customer audits are ... Management Systems (QMS) to assure the site/division is compliant with regulatory , Corporate, and customer requirements. They are responsible for establishing and… more
- University of Pennsylvania (Philadelphia, PA)
- …reviews, amendments, and adverse event reporting. + Prepare and process all regulatory documentation with pharmaceutical companies and CROs. + Obtain the ... CVs and medical licenses, record of IRB certification and compliance ). + Resolve regulatory related queries with IRB, study sponsors and CROs. Qualifications… more
- Drug Enforcement Administration (Arlington, VA)
- …advice regarding the CSA, federal regulations, and policy matters relating to pharmaceutical controlled substances and listed chemicals. Regulatory Drafting and ... Planning and Resources Section, Liaison Section, Policy Section, and the Regulatory Drafting and Policy Support Section. Responsibilities Ensures the evaluation of… more
- J&J Family of Companies (Cincinnati, OH)
- …expanding program capabilities to accelerate innovation, ensuring product safety and regulatory compliance , and guiding cross-functional teams in the integration ... for managing operational aspects of their team (eg, workflow, performance, and compliance ), as well as ensuring achievement of team goals within established… more
- Genentech (Oceanside, CA)
- …This includes managing planned event processes and associated documentation while ensuring regulatory compliance . + **Position 2:** Centers on broader ** ... across teams to resolve challenges, maintain quality system records, and ensure compliance with regulatory standards using cGMP and SOPs. Your responsibilities… more
- Lilly (Lebanon, IN)
- …+ Data Historian + Automated Storage and Retrieval System + QMS * Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, ... to support the process control technical agenda, business plan priorities, and compliance objectives. In the project delivery phase and startup phase of the… more
- J&J Family of Companies (Horsham, PA)
- …located in Horsham, PA or Raritan, NJ. **Position Summary:** Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for IT systems ... Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality… more
- ThermoFisher Scientific (Frederick, MD)
- …and stakeholders. + Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards. + Self-motivated ... and highly skilled, responsible for creating, reviewing, and managing clinical regulatory documents. This role requires a strong understanding of scientific… more
- Merck (Wilson, NC)
- …Engineering Standards, Good Manufacturing Practices (GMP), Manufacturing Process Validation, Regulatory Compliance , Root Cause Analysis (RCA), Strategic ... technical solutions and operational improvements to achieve targets for safety, compliance , supply, and productivity for the product franchise.This role requires a… more
- Merck (Wilson, NC)
- …Interpersonal Relationships, Lean Manufacturing, Management Process, Manufacturing Scale-Up, Regulatory Compliance , Root Cause Analysis (RCA), Strategic ... technical solutions and operational improvements to achieve targets for safety, compliance , supply, and productivity for the product franchise. This role requires… more