- Legend Biotech USA, Inc. (Raritan, NJ)
- …program implementation across all sites.Manage and support the implementation of the internal and external audit program .Schedule, execute, report and ... management of the electronic systems for this program .Work with External Quality and other internal functions to understand and mitigate any compliance… more
- Cipla (Hauppauge, NY)
- …missing records, or other violations are detected. Provide necessary documentation and audit trail reports during internal and external audits (eg, FDA). ... compliance, and performance of IT systems, contributing directly to product quality and regulatory adherence. You will primarily be responsible for validating… more
- Repligen (Waltham, MA)
- …over financial reporting and key digital systems. This role drives the ITGC audit program , advises on risk mitigation strategies, and partners closely with ... Internal Audit , IT, Financial Reporting, and external...ITGC and SOX processes.Utilize data analytics to enhance testing quality , reduce risk, and improve audit coverage.Stay… more
- Merck & Co. (Rahway, NJ)
- …for site projects (capital projects).Participates in regulatory inspections and internal audit processes.Remain current with all environmental regulations ... Goal Setting, Hazardous Material Safety, Incident Investigations, Industrial Hygiene, Internal Audit Controls, Management Process, Manufacturing Standards,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... & Vendor Oversight. This job will interact with Patient Safety, Quality , Vendor and Contract Management, IT, Finance, Contract/Supplier of Customer Engagement… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Finance Responsible for ensuring that all rebate controls meet all audit and internal control (Sarbox) requirements Physical Requirements 0-10% overnight ... responsible for gross-to-net forecasting for the US business, ensuring external and internal customer alignment as necessary. The position is responsible for: Lead… more
- Cipla (Hauppauge, NY)
- …with Good Manufacturing Practices (GMP) and regulatory requirements. Participate in internal audits and ensure compliance with warehouse quality standards. ... 5:00pm Job Overview: The QA Inspector (Warehouse) ensures the quality and compliance of printed packaging materials and warehouse...this position may be eligible for benefits and participation in a bonus program based on performance and company… more
- AUROBINDO (Durham, NC)
- …is complete, accurate, and compliant with regulatory standards5. Compliance and Audit SupportParticipate in internal audits and gap analyses.Support regulatory ... an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory...Match / fully vested after 3 years Employee Assistance Program (EAP) - 100% Confidential and 100% company paid… more
- Insmed Incorporated (NJ)
- …and maintain KPIs, scorecards, and governance frameworks for both internal supply operations and external partnersServe as clinical supply representative ... Clinical Supply Chain to ensure compliance with eTMF documentation and audit readiness activitiesSupport regulatory filings (IND/CTA/IMPD), act as SME during… more
- Insmed Incorporated (NJ)
- …Vault, ensuring compliance with document management standards, version control, and audit readiness.Coordinate the intake, formatting, and QC of regulatory documents ... regulatory archives.Partner with cross-functional teams (Regulatory Affairs, CMC, Clinical, Quality ) to facilitate document authoring, review, approval, and publishing… more
