- Merck & Co. (North Wales, PA)
- …and Compliance and leads global quality support to all internal Animal Health sites, Animal Health External Manufacturing groups and associated functional ... Job DescriptionThe Senior Specialist, Quality Management Systems and Compliance reports to the Director, Animal Health Quality Management Systems… more
- Eisai, Inc (Nutley, NJ)
- …This role will ensure security platforms are configured for optimal protection.6. Security controls and compliance : Collaborate with internal and external ... Risk assessment and mitigation: Collaborate with the Global Security & Compliance team to conduct regular risk assessments to identify potential security… more
- Merck & Co. (Rahway, NJ)
- …execution of IT internal audit engagements to assess the adequacy of internal controls and deliver value add reports. This includes conducting walkthroughs ... to provide reasonable assurance that adequate application and infrastructure internal controls are both designed and operating...Skills:A minimum of three years of IT audit or Risk experienceBasic understanding of security and control … more
- Merck & Co. (Rahway, NJ)
- …performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed.o Performs Quality control visits as ... (including the CTCs, CRAs and COMs).Responsible for creating and executing a local risk management plan for assigned studies.Ensures compliance with CTMS, eTMF… more
- Merck & Co. (Rahway, NJ)
- …colleagues while developing and expanding your career.The Chemistry, Manufacturing & Controls (CMC) Pre-approval Pharm Executive Director is accountable for managing ... Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization (GRACS CMC), will also manage significant cross-modality projects… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …balance sheet reporting as well as well-documented and effective internal controls over tax processes in compliance with Sarbanes Oxley (Sarbox) requirements ... support the Director of US Tax Operations in leading and managing tax operations, tax compliance , tax risk and indirect taxes for Novo Nordisk Inc. (NNI), its… more
- Merck & Co. (Rahway, NJ)
- …This will also require close collaborate with the development engineers & chemists, compliance representatives, and other team member. This role will be part of the ... Facilities Automation Team supporting facility operations, process development activities, compliance investigation, change management and the authoring of GMP… more
- Tris Pharma (Monmouth Junction, NJ)
- …Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating ... incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively,… more
- Insmed Incorporated (Bridgewater, NJ)
- …This position will be accountable for all necessary strategic planning, risk management, operational execution and communication required for the successful and ... achieving its goals & objectives by ensuring program work is conducted in compliance with PMO processes and Company policies and leading organizational and program… more
- Merck & Co. (Durham, NC)
- …key business projects through financial modeling and analysisDevelop, implement and monitor internal financial controls and procedures of the company and assist ... in both internal and external audits including SOX compliance .Actively...that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and make the appropriate changes to ensure trial conduct is completed in compliance and meets Novo Nordisk's business standards Risk management: Assessing and ... and optimization of organization resource allocation. Responsible for managing internal and external strategic collaborations to optimize Operational Excellence and… more
- Merck & Co. (Rahway, NJ)
- …Security DEV/OPSDevelop and implement robust SAP security policies, procedures, and controls .Ensure compliance with regulatory requirements and industry best ... performance, and security through effective monitoring and optimization.Collaborate with internal and external stakeholders to resolve technical issues and implement… more
- Merck & Co. (Durham, NC)
- …in alignment with our high standards of quality. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers, we create an ... biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist will support this expansion.… more
- Merck & Co. (Durham, NC)
- …and safe maintenance and repair of equipment using Hazardous Energy Control Procedures. Compliance with current good manufacturing procedures(cGMP), safety and ... written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs)… more
- Merck & Co. (Austin, TX)
- …existing solutions in Supplier Performance and Analytics and Supplier Risk and Vendor management areas.--Key Responsibilities:- Constructs, amends, and verifies ... destruction of data subject to given objectives regarding security, compliance , policy, scalability, efficiency, reliability, fidelity, flexibility and portability.-… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Develops a comprehensive understanding of the manufacturing processes and the associated risk management control strategy developed to identify process risks and ... with operational deviations and a champion for quality priority principles and compliance within the organization. This is an onsite based role with relocation… more
- Catalent (Harman, WV)
- …the core quality systems, including investigation/deviation management, CAPA tracking, change control , risk management, supplier quality, audits and inspections, ... the QA Systems staff supporting Investigation/Deviation/ CAPA Management, Change Control , Risk Management, Quality Metric Tracking responsibilitiesBuild… more
- Merck & Co. (Durham, NC)
- …area safety, compliance , production and financial goals are metSpare parts risk -based assessments and identification of new parts to replace obsolescent parts to ... with optimized product quality and manufacturing processes and regulatory compliance . GENERAL PROFILE Provides leadership and direction through individual… more
- Merck & Co. (Durham, NC)
- …leak detectors) to facilitate analysis and repair of equipment and control systems.Identifies revisions, deletions, or additions to the calibration and maintenance ... equipment upgrade requirement when needed in order to be in compliance and up to date with calibration.Review's vendor calibration certificates.Maintain working… more
- Merck & Co. (North Wales, PA)
- …manipulate electronic healthcare databases to discover disease prevalence and risk factors, describe drug utilization patterns and disease progression, answer ... and the Biostatistics organization.The position is a key collaborator with internal and external stakeholders including Epidemiology and other functional areas… more
