- Insmed Incorporated (NJ)
- …cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive Director, Cybersecurity & Risk ... risk assessments and develop mitigation strategies CSV Program Oversight : Oversee the CSV team, validation strategy and continuous process improvementEnsure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reconciliation, external data acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk ... reconciliation, external data acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management… more
- Insmed Incorporated (NJ)
- …regionally, and globally.This role can be hybrid or remote.What You'll Do: Primary operational lead over an 1-2 indications within one compound, in collaboration ... we're in. Are you?About the Role:Accountable for providing the leadership, strategic, operational planning and oversight of 1-2 indications within one compound… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with Medical Affairs leaders to assign tasks to remove those gaps. - Provide operational QA leadership and Quality Oversight for the Quality Plan execution, ... QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role involves deputizing for… more
- Insmed Incorporated (NJ)
- …across all Insmed locations and functions. The position will be responsible for minimizing risk to employees, visitors within operational lab assets or in office ... comprehensive EH&S vision, policy framework, and long-term roadmap aligned with Insmed's operational goals and risk profile, including periodic program reviews… more
- Insmed Incorporated (San Diego, CA)
- …outsourced validation vendor when managing cloud applications. Manage and provide oversight on multiple projects simultaneously. Coordinate and lead validation ... associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of validated systems through participating in release… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to contracting and recommend best practices and solutions Proactively conduct comprehensive risk assessments to identify potential legal and operational risks ... Real Estate; Digital, Data and IT; Finance and Tax) and complex and high- risk supplier contracting. Relationships This job reports to the Managing Assistant General… more
- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and combination product programs ... Establish QA-QA relationships and checkpoints for critical CDMOs and service providers. Lead or support Quality Agreements, risk assessments, audits, and… more
- Jobleads-US (Tampa, FL)
- …fail to maintain these standards. Qualifications 10+ years of experience in operational risk management, compliance, audit, or other control-related functions in ... of Cash Services, is responsible for enabling a framework for movement of funds risk and portfolio governance oversight for Citi. Leads strategy and initiatives… more
- Insmed Incorporated (NJ)
- …associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of validated systems through participating in release ... will include, but not necessarily limited to the following: Develop risk -based validation strategies for system implementation and changes following CSV SOPs… more
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