- Novo Nordisk Inc. (Boulder, CO)
- …Nordisk Quality Management System as well as driving continuous improvement projects within the department and/or in collaboration with global colleagues. ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… 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)
- …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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …Lead (CQOL) and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of operational ... commitment to regulatory compliance. Ensures that a cross-functional team (eg Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations,… 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
- 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
- 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
- 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
- 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
- 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
- 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 ... difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and management of financial budgets and… 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. ResponsibilitiesLeadership,… 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)
- …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
- 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
- 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 ... contracting agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management strategy… more
- Lundbeck (Chicago, IL)
- …and psychiatry. Join us on our journey of growth! As an Area Sales Manager (ASM) you will be responsible for leading, developing, and managing a diverse, high ... People Achieves business objectives and sales results by observing Account Manager interactions with target customers, extended treatment team members, ancillary… more
