- BioAgilytix (Durham, NC)
- …you enable life-changing, life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory ... activities for projects including new products and life cycle management . This includes development and implementation of regulatory strategies and timelines as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …skills in designing and implementing innovation/improvement initiatives, including the required change management A minimum of 3 years' experience in ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Position Provides tactical leadership to staff, within the Trial Management (TM) function of North America Clinical Operations (NACO).… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …completed in accordance with business guidance and ethics Identifying opportunities for change management that enhance efficiencies across the contracting life ... ability in identifying areas of improvement and optimization including ideas for change management Demonstrated ability to work independently in a… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... leading centers for oligonucleotide innovation and manufacturing. Together, we are driving change . Are you ready to make a difference? The Position This position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …therapeutic areas. Finally, this position has moderate skills in continuous improvement, project management , change management , and risk management . ... and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control, Client interface, Lab Investigations, Deviations, Complaints, etc. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …define and track measure of success Collaborate with Employee Experience to execute change management activities Practice agile ways of working to identify new ... you in? Are you ready to experiment with us? The Position The Manager , NextGen Customer Engagement will support Novo Nordisk's strong commitment to its customers… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... for oligonucleotide innovation and manufacturing. Together, we are driving change . Are you ready to make a difference? The...ready to make a difference? The Position The Senior Manager of Specialty Raw Materials Manufacturing is responsible for… more
- Catalent (St. Petersburg, FL)
- …Document Control, Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of the ... and to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …, biostatistics, project management ) required- Collaboration, influencing, and change management skills in a complex, matrix environment including ... areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support… more
- Novo Nordisk Inc. (Durham, NC)
- …The Position Establish a satellite team in Manufacturing Development Life Cycle Management (Mdev LCM) in Emerging Technologies (ET) for the production site. Lead ... stability portfolio for all products, and writing and maintaining regulatory documentation. Relationships Director. Essential Functions Lead, drive &...travel up to 10% of the time. (% can change on a case-by-case basis based on the role).… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …requires skills in working in a fast-paced environment, continuous improvement, project management , change and risk management . Responsibilities - ... function to standards team as an extended part of committee. Advise Study Data Manager on complex vendor management issues and provides guidance or feedback to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... good day-to-day management of data at Daiichi Sankyo including: the stewardship...complex points to a variety of stakeholders and drive change through persuasion but not organizational power required- 4… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining ... pertain to training objectives for use at Senior Leadership meetings.Special Projects/ Change ManagementAssist the Director in the implementation of new processes,… more
- Eisai, Inc (Nutley, NJ)
- …jurisdictions.Update IT compliance policies based on regulatory changes.Establish a regulatory change management process for modifying technological ... review adherence to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of regulatory… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Validation principles, guidelines, and industry best practiceDemonstrated history of team management and effecting cross-functional change with strong analytical ... and variances that occur during production or validationWork with Quality, Manufacturing, Regulatory , and subject matter experts to prepare for FDA and other agency… more
- Merck & Co. (Durham, NC)
- … management experience Risk Management experience Experience supporting regulatory inspections- Change Execution Management / Strategy Realization ... experience in a regulated manufacturing industry At least two (2) years of management experience Working knowledge of regulatory requirements in accordance with… more
- Aequor (Libertyville, IL)
- …needs to understand shop floor activities, Good Manufacturing Practices (GMPs), electronic change management , and process automation in addition to prior ... of experience. Must Have List: Knowledge of IT service management platforms to support incident, problem and change...manufacturing and supply chain ERP systems Working knowledge of regulatory requirements and how they relate to existing and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …instrumentation, and computerized systems.Knowledge of quality systems including exception management , change control, document control.Knowledge of operating ... performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate… more
