- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the ... appropriate for the area of GxP audits assigned.Responsibilities:Execute the audit program for internal systems as applicable...objectives and adjust the plan as needed to support business functions and internal stakeholders to execute… more
- Insmed Incorporated (NJ)
- …internal audit function, developing and executing on the annual risk-based internal audit plan.Lead the full compliance program with Sarbanes-Oxley ... business .Coordinate with external auditors to support reliance on internal audit work and streamline audit... Compliance maintains broadly Enterprise Risk Management (ERM), Internal Audit will perform a critical role… more
- Merck & Co. (Rahway, NJ)
- …and assessments across all our Company divisions and functions to evaluate the adequacy of internal controls and deliver audit reports that add value to the area ... and techniques to independently assess risk and evaluate the effectiveness of internal controls in business scenarios in accordance with timelines.Applies body… more
- Merck & Co. (Rahway, NJ)
- …Experience and Skills:A minimum of 3 years work experience in internal audit , public accounting, or general accounting.Experience with ... Accounting Firm Experience.Required Skills: Accounting, Accounting, Adaptability, Asset Accounting, Audit Internal Controls, Contract Audits, Data Analysis,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related to Adverse Event reporting and quality tasks performed by suppliers and business partners to ensure compliance with SDEA requirements. Relationships This ... limited to the following: all units in Patient Safety, NAO QA, NNI Legal, NNI Compliance , NNI Commercial, NNI Finance, Global Business Services (GBS), PV & GDP… more
- Cipla (Hauppauge, NY)
- …focus on audit trail review, data integrity, and overall GxP compliance . Responsibilities: Perform detailed reviews of the equipment audit trails associated ... of the batch records (manufacturing and packaging) to ensure compliance with GMP, regulatory standards, and internal ...or other violations are detected. Provide necessary documentation and audit trail reports during internal and external… more
- Tris Pharma (Monmouth Junction, NJ)
- …ensure timely and accurate delivery of financial information and support the company's business objectives. Ensures compliance with GAAP across all revenue and ... research and documentation; Drafts white papers and accounting memos to support audit and regulatory compliance Provides guidance on new accounting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met Audit & Inspection Readiness Support the ... processing issues and provides support and escalation channels for both internal teams and external stakeholders, including patients and healthcare professionals,… more
- Cipla (Reid, WI)
- …River, MA Work Hours: General Shift: 8:30AM - 5:00PM (may vary based on business needs) Reports To : Department Head - Manufacturing Salary Range: $72,800 - $93,600 ... Manufacturing and partners with cross functional team members to ensure compliance and operational success through user focused documentation at InvaGen… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Coordinate document reviews, approvals, and revisions, ensuring timely updates and compliance with internal and external requirements Monitor and track ... against established metrics Prepare and present regular reports on documentation compliance , audit results, and improvement initiatives to senior management… more
- Cipla (Hauppauge, NY)
- …SOPs, and other documents related to manufacturing processes. Ensure batch records are audit -ready and fully compliant for both internal and external audits (eg, ... complies with Good Manufacturing Practices (GMP), regulatory standards, and internal quality assurance procedures. This role ensures the integrity, accuracy,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position The position is responsible for gross-to-net forecasting for the US business , ensuring external and internal customer alignment as necessary. The ... next Generation platforms, current generation model enhancements and creation/implementation of Business Intelligence platforms Serve as internal consultant with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sources. The Director is responsible for mentoring coaching and meeting the compliance requirements for the Medical Review Team. Relationship Reports directly to ... and Strategy for case-related risks and operational challenges Collaborate with internal stakeholders to proactively identify and mitigate potential issues … more
- Cipla (Fall River, MA)
- …River, MA Work Hours: 1st Shift: 7:00AM - 03:30PM (May vary based on business needs) Reports To: Site Warehouse Manager Salary Range: $64,272 - $77,662Purpose: The ... with purchase, production, etc. to support manufacturing effectively and ensure compliance to cGMP and safety.Multifunctional Role:This job is a multifunctional… more
- Eisai, Inc (Nutley, NJ)
- … business '; lead global initiatives for continuous improvement.Trend and leverage internal audit and industry intelligence relating to inspections and share ... and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality… 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 operations. This includes reviewing… more
- Warner Music Group (New York, NY)
- …way. Our work includes SOX, operational audits, and proactive risk management for the business . The Internal Audit department partners with the business ... creative spirit of a nimble independent. **Job Title: Manager, Internal Audit ** **A little bit about our...the biggest positive impact. We strive to be valuable business advisors that provide meaningful insights and solutions, not… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cell therapy clinical manufacturing process.Support manufacturing activities for cGMP compliance through spot checks/ internal audits.Collaborate with site ... responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities… more
- Genscript USA Inc. (Piscataway, NJ)
- …processes remain compliant with company policies and regulatory standards. Respond to internal and external audit challenges by providing complete and accurate ... collaboration with cross-functional teams is essential to ensure supply continuity, compliance with quality and regulatory standards, and readiness for audit… more
- AUROBINDO (Durham, NC)
- …control.Ensure documentation is complete, accurate, and compliant with regulatory standards5. Compliance and Audit SupportParticipate in internal audits ... assuring that the investigations are conducted and written in compliance with all cGMP regulatory as well as facility...Light to moderate lifting is required Moderate noise (ie business office with computers, phone, and printers, light traffic).… more
