- Legend Biotech USA, Inc. (Raritan, NJ)
- …effectively determine appropriate resolutions that ensure compliance and minimize risk .Must exhibit strong leadership skills and effectively develop others.Ability ... to collaborate well with stakeholders, customers and peers.Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.Must be able to discern the criticality of issues and communicate to management regarding… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of ... computer systems validation, equipment, utilities, and facility qualification, process validation, shipping validation, and data integrity.Key ResponsibilitiesProvide quality and compliance oversight for computer systems validation, process validation,… more
- Cipla (Fall River, MA)
- …deviations. Develop, implement and assess solutions for complex problems. Anticipates risk and builds contingencies to help mitigate impact. Reviews document for ... accuracy and completeness. Defends the validation programs and strategies to customers and regulatory auditors. Performs weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate protocols. Follows strict… more
- SMBC (New York, NY)
- …SMBC is seeking an Associate with commensurate experience / skills in credit risk analysis for US subsidiaries of Japanese parent companies. + Review & challenge ... analysis and the review includes, but not limited to, obligor credit risk , projections, transaction background, deal structure, facility terms and conditions, US… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …reported to Olympus. Independently recommends and drives escalation of key events. + Risk Management: Is considered an expert in risk management principles, ... as medical subject matter expert in the development of pre/post market risk assessments and risk management file documentation, specifically providing… more
- SMBC (New York, NY)
- …in providing foundational data and analytics that enable accurate pricing, risk assessment, and trade decision-making across global markets. **Role Objectives** + ... own the roadmap for pre-trade analytics platforms, ensuring alignment with trading, risk , and regulatory objectives. + Prioritize features that enhance data quality,… more
- Banc of California (Escondido, CA)
- …deterioration, as applicable. Conduct annual reviews of loans and identify any risk rating changes. Keeps apprised of industry related, political and regulatory ... and commercial real estate loans. + Performs independent credit analysis and risk assessment of existing credit requests. Including, but not limited to, preparing… more
- Insmed Incorporated (NJ)
- …assess regulatory risks associated with product development and define risk -mitigation strategiesProvide regulatory guidance across functions throughout the R&D ... process and advise on the US IND and global CTA submission strategiesDirect the planning and coordination of global regulatory submissions, including clinical trial applications for multinational trials, core briefing packages, and global marketing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change controls, draft industry ... guidelines, specification & critical limitsDevelop and align a variety of process validation documentation templates ranging from control strategies to PVP and PPQ templatesSupport global initiatives related to quality/compliance/validation (APS benchmarking,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Automation and GMPs requirements preferred Broad understanding of science and risk -based verification (IE ASTM E2500) Knowledge of good engineering practices ... Excellent written and verbal communication skills a must Excellent communication skills and ability to work in a high-paced team-oriented environment Ability to provide evening, nighttime, and weekend on call support as needed Technical requirements for… more
