- Eisai, Inc (Exton, PA)
- …CTAs) and agency communications (responses to questions) are prepared in compliance with the applicable regulatory requirements and scientific ... Job Summary Implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of pharmaceuticals. Coordinates the… more
- Tris Pharma (Monmouth Junction, NJ)
- …leadership and direction for Clinical Quality Assurance Operations, ensuring compliance with regulatory standards and driving implementation and continuous ... Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director/ Senior Director, Clinical Quality Assurance. This is a hybrid position.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Readiness: Oversee and or participate in internal audit programs and lead IS quality audits to ensure regulatory compliance and successful outcomes. ... Exela Pharma Sciences is seeking an experienced and dynamic Senior Manager, IS Quality to build and...in the operational execution of Quality and Compliance GxP processes including audits, regulatory intelligence,… more
- Merck & Co. (Rahway, NJ)
- …the highest regard for our Company divisional and local site procedures for safety, quality , and regulatory compliance .Understand the big picture, and how ... stakeholders include our Company Manufacturing sites, External Manufacturing, R&D, Quality , Operations, Product Development groups, Regulatory Affairs,… 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, ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Merck & Co. (Durham, NC)
- …Chromatography, Homogenization, Process Monitoring, Sampling, and area cleaning. As a Senior Technician you will be an energetic leader with strong interpersonal, ... and other materials as required to appropriate laboratories, coordinating with Quality and Logistics as required.Performs housekeeping in all work areas. Executes… more
- Merck & Co. (Rahway, NJ)
- …be responsible for overseeing the day-to-day operations of the laboratory, ensuring compliance with safety regulations, maintaining quality control, and managing ... Job DescriptionPosition Description: Senior Scientist, Microbiology (Lab Lead) - Analytical Research & Development (Onsite) Small Molecule Analytical Research and… more
- Merck & Co. (Rahway, NJ)
- …biologics, vaccines, antibody drug conjugates (ADCs), in addition to others.- --The Senior Specialist, Engineering will serve as a business representative in the ... with formulation scientists, Global Engineering Solutions (GES) engineers, Safety and Quality representatives, Digital and IT, equipment vendors, and other team… more
- Merck & Co. (North Wales, PA)
- …data management conceptsExperience in CDISC and ADaM standardsExperience ensuring process compliance and deliverable quality .Strategic thinking - ability to turn ... stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance . Strong working knowledge of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and focus even under adversity Operational mindset and continuous improvement: Considers compliance , regulatory , quality assurance and other requirements ... this leader enables all activities related to the successful acquisition of high- quality goods/services at the best possible prices and business terms for NNI.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …efficient execution of critical quality tasks. Fostering efficiency, maintaining compliance with cGMP and other relevant regulatory requirements, and ... documents, such as Standard Operating Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research...a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …various subunits of the Quality System and ensuring accountability. Achieving compliance with cGMP and other relevant regulatory requirements and fostering ... documents, including Standard Operating Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …practices, digital spaces, Marketing and Regulatory /Legal aspects to ensure compliance with legal, quality and industry standards for customer engagement ... enhance TA-specific customer experiences; building strong cross-functional relationships; ensuring compliance to Legal, Regulatory and industry standards;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements ... ensure adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP...Metrics in a periodical manner and communicate this to Senior Management handling Quality Meeting sessions, identifying… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… 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 ... multidisciplinary team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound… more
- Merck & Co. (Millsboro, DE)
- …and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for ... at our company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as applicable to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and enablement strategies to guide optimization decisions Strong understanding of regulatory , compliance , and ethical considerations in engaging with healthcare ... Experience and Marketing Enablement organization. This role involves partnering with senior management and capability owners to implement best practices, governance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of omnichannel best practices, Marketing and Regulatory /Legal aspects to ensure compliance with legal, quality and industry standards for customer engagement ... enhance TA-specific customer experiences; building strong cross-functional relationships; ensuring compliance to Legal, Regulatory and industry standards;… more
