- Insmed Incorporated (San Diego, CA)
- …compounds, and is responsible for the management of ongoing and cross functional assessment of benefit- risk profiles and related actions, including writing and ... Senior Director will be responsible globally for executing the safety and risk management activities. This individual is responsible for safety surveillance, risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …site differentials, following the critical variables defined during RBQM Risk Assessment .Responsibilities:CSM Execution: Provides tactical approaches and leads ... study resource requirements, and supportive technology (as needed), for the risk -based central monitoring function.Interacts with and influences internal … more
- Novo Nordisk Inc. (Durham, NC)
- …system, such as 21 CFR Part 11, GAMP5, ISO, Data Integrity preferred Experience with Risk Assessment & Vendor Assessments required Minimum of four (4) years of ... and Inspections. The Sr. QA Area Specialist will host internal audits, serves as facilitator during and coordinate all...root-cause analysis tools & techniques a plus Experience with Risk Assessment & Risk Management… more
- Formation Bio (New York, NY)
- …actions (CAPA effectively. Proficiency in quality management tools and methodologies (eg, risk assessment , root cause analysis, FMEA) and quality management ... controlled documents outside of QA. Assure the execution of QA Audit Plans, Lead internal and external audits to assess compliance with regulatory requirements,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(IRBs), and other site personnel as neededStudy-specific subject matter expert (SME) for internal audit or Health Authority (HA) questions related to medical ... for one or more clinical trials. Matrix management responsibilities across the internal and external network. Manages Phase 1-3 studies (depending on assignment)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …work procedures/guidance, logs, templates, quality procedures, risk impact assessment mitigation procedures, to maintain audit readiness, data integrity, ... requests from study team members, periodic review of user access and audit trail reconciliation, impact analysis and documentation of identified access discrepancies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and approval of documents associated with validation or qualification activities, risk assessment strategies, technical studies and applicable changes that ... FDA premises and regulation, another applicable GMP guidelines and internal DS policies, procedures or standards. The incumbent is...risks at CMO's and support the recommended courses of risk treatment and resolution manner in appropriate way and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and approval of documents associated with validation or qualification activities, risk assessment strategies, technical studies and applicable changes that ... FDA premises and regulation, another applicable GMP guidelines and internal DS policies, procedures or standards. The incumbent is...risks at CMO's and support the recommended courses of risk treatment and resolution manner in appropriate way and… more
- Adecco US, Inc. (Westminster, CO)
- ** Internal Audit & Risk Assessment Analyst** **Location:** WESTMINSTER, CO 80021 **Pay Rate:** $ 69.83/hour **Summary:** We are seeking a detail-oriented ... and analytical Internal Audit & Risk Assessment Analyst to join our team. This role will be responsible for conducting internal audits, assessing… more
- RTX Corporation (Farmington, CT)
- … stakeholders to understand, document risks and communicate the risks internally as part of the Internal Audit risk assessment and to audit teams ... implementing a new process in the AuditBoard Risk oversight tool for the Internal Audit Risk Assessment and ERM process + Conduct training sessions… more
