- Merck & Co. (Rahway, NJ)
- …degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management in a regulated ... functional areas.Drive accountability for processes execution throughout GRACS through change management .-Develop, implement and report process objectives and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ... and current regulatory requirements tracking all the complaints, deviations and change control related with the product and creating a trend evaluation scenario… more
- BioAgilytix (Durham, NC)
- …responsible for assisting in providing quality oversight of equipment management , reviewing mapping qualification reports and reviewing calibration certificates. He ... Computer System Validation Status listing and the Master Equipment listing Assist during regulatory agency and sponsor inspections Review and approve site change … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents ... ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... in a manner that facilitates Health Authority reviews.- Supports company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and Compliance GxP processes including audits, regulatory intelligence, regulatory inspections, change management , and quality risk management ... Develop and implement IS governance policies and procedures to ensure effective IS management and compliance . Change Management : Establish and manage… more
- Insmed Incorporated (San Diego, CA)
- …budget for drug product shipments.Own and support stability and sample management -related Deviations, CAPAs, and Change Controls. Drive related ... related topics.Establish and publish Key Performance Indicators (KPI) to track cGMP compliance for stability studies and sample management . Capture metric… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …knowledge in maintenance/metrology management , broad understanding of facilities management , cGMP compliance , EHS and regulatory standards ... preventative maintenance (PM) & predictive maintenance (PDM) practices to ensure compliance (cGMP) with company policies and appropriate regulatory … more
- American Honda Motor Co Inc (Marysville, OH)
- …to Bring the Future!About this Position: Support department and plant environmental regulatory compliance (CAA, CWA, RCRA, EPCRA, SWPPP, SPCC) and sustainability ... management systems to efficiently track and manage environmental compliance /performance.Coordinate assigned contractor SOW(s) (Scope of Work) (eg waste … more
- Novo Nordisk Inc. (Atlanta, GA)
- …Complies with all guidelines, policies, legal, regulatory , and compliance requirements Ensures effective administrative management of regional business ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Penske Truck Leasing Co., LP (Delaware, OH)
- …with communication, training, feedback, and direction to ensure safe performance Ensure compliance with all applicable regulatory agencies and company policies ... Do you have a demonstrated ability to drive process improvement and lead change ? Penske Logistics is seeking a proven leader with relevant experience and skills… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Governance Stewardship will work in areas required for the good day-to-day management of data at Daiichi Sankyo including: the stewardship organization, data ... quality, metadata management , lineage capabilities and the data governance processes surrounding these capabilities, and the data governance program in general. This… more
- American Honda Motor Co Inc (Marysville, OH)
- …establishing processesExperience in bringing projects from idea to implementationFamiliarity with regulatory and compliance requirements and concepts of resource ... and business strategy in a world of rapid technological and social change requires a highly capable, highly knowledgeable, and highly engaged team. Sustainability… more
- Merck & Co. (North Wales, PA)
- …and trainingPartnership in managing, prioritizing, and implementing portfolio projectsDrive compliance initiatives, change management and communication ... compliance with departmental and company Standard Operating Procedures, regulatory requirements, and standards.- Primary Activities :Business System Ownership… more
- Aequor (Bothell, WA)
- …including 21CFR part 11, and good documentation practices. Knowledge of IT service management platforms to support change IT operational events (ie ServiceNow). ... system owners and Quality in accordance with company procedures and regulatory requirements. Author, review and/or approve applicable CSV documentation Assist… more
- Eisai, Inc (Nutley, NJ)
- …or user acceptance testing, and integrations with other clinical applications through change management . Maintains the eTMF system including secure storage, ... relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws...and serve as a subject matter expert in TMF Management . This position may be office-based (hybrid) in… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …report contains the technical merit and completeness according to regulatory expectations. The Deviation Investigator-Writer will be responsible for initiating ... Deviation Response Team team and a champion for quality priority principles and compliance within the organization.This role is a full-time onsite based role at our… more
