- 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 ... regulatory requirements as appropriate through customer complaints, internal audits and training systemsConduct trainings and/or communicate appropriate materials,… more
- Merck & Co. (Rahway, NJ)
- …experience.Demonstrated history of interacting with site, divisional or regulatory audits .Strong communication (written/verbal), and multi-tasking ... Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the 24-hour… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Develop expertise in one or more focus areas (SME) Involved in audits /inspections for safety surveillance and risk management for assigned clinical studies, through ... Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs) - Contributes to regulatory authority requests or communication for assigned clinical studies - CTD… more
- Merck & Co. (Durham, NC)
- …of the team (eg documentation, housekeeping, area 5S, etc.)Participate in safety/ regulatory audits (ie tours, topic discussion)FinancialCoach the team to ... Job DescriptionThe role of Operations Manager at our Company's Durham facility is a...environmentElectronic manufacturing systems (eg PAS-X, SAP, Delta-V, etc.)Interacting with regulatory auditors as part of area tours and/or topic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies ... the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …HHS and DCA audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also oversee the daily operations of ... Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract… 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, ... GxP Support processes, including but not limited to Document Management and/or Audits and Inspections, as necessary Provide guidance and/or training to less… more
- Catalent (St. Petersburg, FL)
- …technical transfers and routine production.Provide support to internal, client, and regulatory audits .Engage in monitoring quality systems to maintain awareness ... Manager , QA (Product Development)Position SummaryThe Quality Assurance Department...as it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines).Provide QA Technical support during the development and… more
- Catalent (St. Petersburg, FL)
- …to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support ... to Quality Systems, Finished Product Batch Release, Training, Internal/External Audits , Complaints, APR, Investigations, Document Control, Equipment/Facilities, Change Control,… more
- Tris Pharma (Monmouth Junction, NJ)
- …but not limited to: investigative processes, CAPAs and CPIs, etc.Participates in regulatory agency inspections and customer audits , as needed; Performs and/or ... New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager ,...participates in internal and external audits , as neededManages, coaches and mentors direct reportsAny other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …plus Strong knowledge of cell therapy process preferred Experience in cGMP regulatory body audits Strong interpersonal and written/oral communication skills ... multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in...in Raritan, NJ. Role Overview The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …facility, and deviation issues Assists in performing and reporting internal and vendor audits as scheduled Participate in Regulatory Inspections Performs all job ... QA presence on the manufacturing floor. Essential Functions Performs walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality… more
- Merck & Co. (Rahway, NJ)
- …issues related to protocol conduct,-recruitment, retention, protocol deviations, regulatory documentation, site- audits /inspections and overall site ... Job DescriptionWith support of Sr CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead ... and Quality Control to resolve open issues resulting from record reviews, internal audits of the facility, and deviation issues Performs vendor audits as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements. Participates in audits as an external data management ... providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose strategies for external data… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate ... with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, USP, and...for assigned areas and participate in internal and external audits as SME for department and respond to audit… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- PwC (New York, NY)
- …to be successful and progress in our careers, now and in the future.As a Senior Manager , you'll work as part of a team of problem solvers, helping to solve complex ... large corporate tax functions, by monitoring and analyzing legislative and regulatory tax developments, developing strategies in anticipation of tax law changes… more
- Sunrise Senior Living (Chicago, IL)
- Overview The LPN Medication Care Manager is responsible for providing the highest degree of quality care and services by administering medication and treatments in a ... to supervisor. Counts all narcotics with another Medication Care Manager (MCM) or Lead Care Manager (LCM)...standard care precautions of cleanliness, hygiene, and health . Audits medication carts.Resident Care: Notifies RCD of any resident… more
