- Merck & Co. (Rahway, NJ)
- …our Biologics Science & Technology (S&T) portfolio. In this high-impact role, you'll lead the Drug Substance Working Group (DSWG), mentor scientific talent, and ... and Planning, Immunochemistry, Maintenance Supervision, Mammalian Cell Culture, Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Systems , Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of...rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … standards are met.Proactively assess and address operational gaps related to quality systems and compliance, fostering a culture of sustainable ... validation of IT services and determining audit targets for GxP systems .ResponsibilitiesLeadership and Strategic DirectionThe Sr. Director, Data Quality and… more
- BioAgilytix (Durham, NC)
- …That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can ... keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, with hands-on… more
- Repligen (Clifton Park, NY)
- …for a Production Lead in the Repligen Injection Molding and Packaging manufacturing group . The lead will be responsible for the safe manufacture of product, ... addition, this role will be required to assign, track, lead , and plan orders to completion to the production...those into the process.Compliance with all aspects of Repligen's Quality Management system and Quality … more
- Novo Nordisk Inc. (Durham, NC)
- …preferably in the pharmaceutical industry Demonstrated expertise in Regulations & quality systems (eg, commercial product disposition, DV/CAPA, Change Control, ... processes. Relationships Reports to Manager, QA. Essential Functions Ensure plant systems batch release & relevant quality processes are compliant with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …DS group including business units, functional units and corporate functions. Lead Training function team and Document and record management function team to ... a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of...matrixed global teams environmentMust have a broad understanding of quality management system , GxP regulations and industry… more
- Merck & Co. (Durham, NC)
- …technology systems , and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, ... leadership and implementation of troubleshooting activities and change control.Initiate and lead collaboration within the Operations, Quality and Technical… more
- Merck & Co. (Durham, NC)
- …technology systems , and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, ... and implementation of troubleshooting activities and change control. Initiate and lead collaboration within the Operations, Quality and Technical organizations… more
- Merck & Co. (Durham, NC)
- …provides the best in class services with the final goal of delivering our high- quality vaccines to the patients around the worldWith our core principle of Safety ... First and Quality Always EMSS strives to have the safest and...customer service-oriented leader to support the VMF IPT. Will lead the tactical and strategic equipment reliability improvements, human… more
- Merck & Co. (Durham, NC)
- …staff - Support Talent Management.Direct, coordinate, provide guidance and counseling to group leaders to assure optimum quality and quantity of finished ... input in the design process, startup their areas, and lead the teams to full production.-The ideal candidate for...that Shift(s) objectives are achieved while reliably supplying a quality product at a competitive cost consistent with our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …DSI new computing environment system for programming and analysis efficiency, identify system bug/issue and lead the activity to enhance the system , ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve… more
- Merck & Co. (Durham, NC)
- …provides the best in class services with the final goal of delivering our high- quality vaccines to the patients around the worldWith our core principle of Safety ... First and Quality Always EMSS strives to have the safest and...customer service-oriented leader to support the VMF IPT. Will lead the tactical and strategic equipment reliability improvements, human… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Quality professionals at strategic non-project team and at MA strategic discussions. Lead the Quality Reviews of respective product profile to ensure ... Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of...and risk management in close collaboration with the organization's quality management system , to assure robust knowledge… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... Support validation activities associated with changes to existing & new systems . The incumbent will set requirements, build/construct, design, commission & perform… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Controls and Impact Assessments for Engineering/Facilities qualification projects.Participate and lead in the development of corporate-wide systems , procedures, ... of facility and equipment for new projects and existing qualified systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... to a strong portfolio of medicines for cardiovascular diseases, under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage… more
- Merck & Co. (Rahway, NJ)
- …Automation, Safety, Technical Services, Process Development, Analytical, Regulatory, and Quality .As part of Our Company's Manufacturing Division, within the ... and post-market commercial manufacturing processes for vaccines and biologics. The group supports various cell bank and upstream drug substance process… more
- Novo Nordisk Inc. (Boulder, CO)
- …updating Customs Standard Operating Procedures (SOP's) as needed Authoring and implementing quality management system policies and SOPs for process establishment ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...a key SME in the area to support and lead process improvements. Relationships This position will report to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …training and support materials for end-users, handling of queries, troubleshooting, and quality control. Lead or support consulting and implementation projects in ... Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve… more
