- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …effectiveness checks on process implementations and metrics. Support continuous process improvement , interpretation of regulations, quality and compliance with ... effectiveness checks on process implementations and metrics. Support continuous process improvement , interpretation of regulations, quality and compliance with… more
- Merck & Co. (Millsboro, DE)
- … Quality Control (QC) Associate Specialist, with Guidance from the QC Manager , ensures product/process quality through the review of GMP documentation and ... Job DescriptionOur Quality group ensures every single material inside our...and release of bulk antigen and raw materialDrive process improvement using Six Sigma and MPS tools.Participation in project… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems records. Implement and lead CAPA site governance program. Drive continuous improvement of quality systems processes. Implement processes to ensure ... the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the ...Quality Systems Lead role as part of the Quality Operations team based in Raritan, New Jersey. Role… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people. This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... a team of individual contributor production direct reports including safety, quality , and daily operations;Ensure that Shift(s) objectives are achieved while… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development ... areas. Finally, this position has moderate skills in continuous improvement , project management, change management, and risk management. Responsibilities Leadership,… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... and could include all or some aspects of the Quality function.The Product Development QA Manager provides...the clients with products that have technical opportunities for improvement . The QA Manager will act as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global Quality departments to review ... policies and procedures in collaboration with global DX and global Quality departments. Evaluates key performance indicators and participates in SDLC Lessons… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... activities, which include the receipt, documentation, triage, case review, and quality assessment of all inbound safety information, including serious and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Unit operational activities for developing collaboration site, internal process improvement , developing business process and system integration. Contribute and ... Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and successful… more
- Merck & Co. (Durham, NC)
- …procedures to resolve process/equipment issues, minimize downtime, and ensure product quality .- This role actively supports, participates, and embraces an inclusive ... team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required. Primary activities for this position… more
- Catalent (St. Petersburg, FL)
- …and to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management ... St. Petersburg site. The Department has the responsibility for Quality aspects including but not limited to Quality...Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). Manages mutually… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role ... Overview The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. Drive continuous improvement… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at ... for their clients within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …define and manage service-level agreements (SLAs), ensuring compliance and high- quality service delivery- Monitor vendor performance, conduct regular evaluations, ... vendor services- Identify and recommend cost-saving opportunities without compromising quality or attendee experience.Vendor Training - Design and deliver… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse...the collection of diverse external data types.Advises Study Data Manager on complex vendor management issues and provides guidance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... optimizing the defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operational issues in a timely manner and continuous RPM process improvement with focus on quality , reliability, consistency and efficiency.ResponsibilitiesPlan, ... areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning and… more
