- Merck & Co. (Rahway, NJ)
- …to what is described in the Pipeline Advertisement.Expand your skills and experience in audit through a career path in the pharmaceutical industry. Become part of a ... impact on patients' lives.Under the direction of the Client Audit Director (CAD) and the Auditor-in-Charge (AIC), the Senior...our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management… more
- Merck & Co. (Rahway, NJ)
- …support and participated in planning and co-ordination of pharmacovigilance (PV) audit activities within our company and externally with CRO's, laboratories, ... and Preventive Actions (CAPA)s which are necessary due to audit findings.Assure maintenance of audit data in...and verbal communication skills in English.Ability to facilitate and/or lead a variety of meeting formats.Ability to perform in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems ... Partner with global Quality departments to review global policies, inspections and audit CAPAs, and vendor audit documentation.- Author, update and maintain… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible to support Clinical Inspection Readiness (IR) and ... the scrutiny and questioning of a sponsor pre-approval inspection.Post inspection, audit , quality review, investigational panel or other identified sources, gather,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in Raritan, NJ. Role Overview ... The Quality Compliance- Lead Auditor CAR-T is responsible for regulatory compliance supporting...support the implementation, execution, and improvement of the internal audit process. Support the planning and execution of internal… more
- Eisai, Inc (Nutley, NJ)
- …incidents.Conduct annual tests and address vulnerabilities.Analyze threat data and lead hunting efforts.Deploy standards, conduct training, and track KPIs.Define ... compliance issue resolution.Report compliance risk levels to key stakeholders.Coordinate audit readiness and resolution.Align IT compliance budget with risk appetite… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path ... for assigned clinical study (-ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross-functional Clinical Study Oversight Plan… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the ownership and maintenance of GCO-owned procedural document packages. Lead authoring, review, and periodic reviews/updates for all GCO procedural ... appropriate, provide support for GCO process improvement activities, projects, inspections and/or audit findings resulting in the need for either a new procedural… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …HCM Platforms and processes. This position will act as the functional lead with technical and operational expertise across multiple HRMS applications, possessing ... and maintenance of the Company's global HRIS system (ie, SAP SuccessFactors). Lead respective workstream(s) to gather, document, implement and validate all system… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Manufacturing Lead Operator as part of the Technical Operations team based in Raritan, ... to develop professionally. Support investigation efforts as required. Responsible for audit preparation and participation. Requirements HS Diploma required with 8-10… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …site personnel as neededStudy-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to medical monitoringFor studies ... when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in ... safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and cross-functional team in support of benefit… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …affiliates. Proactively supports Global QA CMO Management and Global QA Audit Program teams.Responsible to ensure that quality improvement initiatives at Global ... advise the GMP road map to meet changing regulatory and business needs. Lead remediation and risk management to assure the organization's Quality Management System… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …site personnel as needed- Study-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to medical monitoring- For studies ... needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the… more
- Eisai, Inc (Nutley, NJ)
- …etc.) across the Americas. Reporting to the Americas Infrastructure Lead , the associate provides extensive, broad-based technical leadership, management experience ... expertise to guide their respective teams. As a regional Infrastructure function lead , the associate will also interface with global stakeholders to seek synergies… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support for data integrity assessments within the laboratory. Take the lead in managing Equipment Lifecycle Management processes, including overseeing change control ... Operating Procedures (SOPs) for equipment operation. Conduct regular reviews of system audit trails / periodic review to ensure data integrity and compliance. Manage… more
- US Bank (New York, NY)
- …skills and discover what you excel at-all from Day One. **Job Description** The Audit Methodology Lead supports the Head of Professional Practices and the ... Professional Practices Senior Audit Manager in maintaining the Corporate Audit ...revised IIA standards, guidance, and publications; make recommendations and lead the implementation of any action plans. + Perform… more
- MUFG (New York, NY)
- …of our recruitment team will provide more details. **Job Summary:** The Senior Credit Risk Audit Lead is a management role within the Internal Audit function ... prepared by staff and enforcement of application of methodologies. The Senior Audit Lead provides thoughtful leadership, helps to enhance the department's… more
- Justworks (New York, NY)
- …leadership and technical guidance for compliance with Sarbanes-Oxley (SOX) regulations. + Lead the operational/financial audit team as the management advisor and ... Justworks in a complex business process environment. + Maintain the audit universe and lead continuous risk monitoring and Enterprise Risk Management and align… more
- City of New York (New York, NY)
- …conducting GAGAS performance audits and reviews with small teams consisting of Audit Supervisors, Lead Auditors, and Staff Auditors. The Assistant Comptroller ... paying attention to the long-term challenges we face together. The Audit Bureau conducts informative and meaningful audits, independent assessments, and objective… more
