- Cipla (Fall River, MA)
- …standards to meet the regulatory requirement and to ensure audit readiness . Ensure proper receipt, verification, segregation, storage, labelling and accounting of ... issuance Maintain sanitation and hygiene in stores facility to ensure audit readiness Ensure correct status labelling for materials, accessories and equipment by… more
- Eisai, Inc (Nutley, NJ)
- …and compliance with ICH/GCP guidelines and local regulations, ensuring inspection readiness and adherence to corporate standards.As a key influencer, the position ... outsourcing activities, and collation of documentation to ensure inspection readiness .Provides guidance to Eisai affiliated companies in undertaking global… more
- Insmed Incorporated (NJ)
- …ensuring compliance with document management standards, version control, and audit readiness .Coordinate the intake, formatting, and QC of regulatory documents prior ... with Veeva Submissions Vault for document management and submission readiness .Hands-on experience with eCTD publishing tools (eg, Lorenz, GlobalSubmit, Extedo,… more
- Eisai, Inc (NJ)
- …Director drives operational excellence, risk mitigation, and inspection readiness while fostering cross-functional collaboration and innovation.The position requires ... global outsourcing team and oversees collation of documentation to ensure inspection readiness on a regional Provides guidance on outsourcing SOPs and work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and collaborate closely with Operations Associates and Management to facilitate readiness of trainees and effective process qualifications. The role will require ... cross functional groups to enable robust training, regulatory compliance, team readiness , and processing of product prior to release to patients.Key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including investigator grants and pass through costs.- Quality and inspection readiness -Support inspection readiness and quality initiatives pertaining to ... assigned study(ies).-Serve as primary SME engaged in dialogue with inspector(s) to address study inquiries throughout course of HA inspection-Ensure trial master file is complete and accurate for assigned stud(ies).-Ensure that a study level operational risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategy for Companion Diagnostics (CDx) across the oncology portfolio, driving readiness , scientific leadership, and strategic alignment with internal and external ... partners.- Drive global medical readiness for CDx launches and lifecycle management across the oncology portfolio, ensuring timely, integrated execution- Ensure… more
- Insmed Incorporated (NJ)
- …their lifecycle a plus .Familiarity with validation of documentation, audit readiness , and continuous improvement of CSV processes. Risk Management: Define and ... with GxP regulations and industry standardsFamiliarity with validation of documentation, audit readiness , and continuous improvement of CSV processes a plus . Team &… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …this role will support Compliance initiatives, such as inspection readiness , metrics implementation and review, overall regulatory compliance and implementation ... to stay informed of regulatory trends and developmentsAssist with inspection readiness efforts and program implementation across all sites.Manage and support the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and collaborate closely with Operations Associates and Management to facilitate readiness of trainees and effective process qualifications. The role will require ... cross functional groups to enable robust training, regulatory compliance, team readiness , and processing of product prior to release to patients.Schedule: Mon-Fri,… more
