- Novo Nordisk Inc. (Plainsboro, NJ)
- …to enable compliance with QMS process requirements across NNI and global as applicable Proactively identifies risks/ quality drift in external vendor and ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across NNI and global as applicable Proactively ... ensuring highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …enable compliance with Deviation process requirements across NNI and global as applicable Develops and executes regular surveillance, follow-up, and reporting ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Global , Regional and Local Leaders. Interacts with other HR colleagues, global colleagues, legal and compliance , employees and hiring managers at all ... Are you ready? The Position Responsible for leading process, reporting and compliance related activities for US Talent Acquisition. Responsible for oversight of… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and ... in compliance with cGMP and regulatory filings. Perform independent quality review and approval of batch records, testing data, and related documents… more
- Merck & Co. (Millsboro, DE)
- …striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, ... along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit… more
- Repligen (Waltham, MA)
- … Quality team. You will a key role in ensuring the quality , compliance , and performance of Repligen's global supplier base. This is an opportunity to ... is based in Waltham, MA, and will report to the Senior Manager of Supplier Quality .Responsibilities Supplier Performance Monitoring and ReportingCollect,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reconciliation with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical Information Social Media and ... and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi ... for purpose and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Durham, NC)
- …striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, ... and implementation of new systems which enhances the operation and/or engineering processes. Quality & Safety Compliance :The successful candidate should be able… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are ... and cutting-edge therapeutics for patients worldwide.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies… more
- Merck & Co. (Rahway, NJ)
- …will require routine interaction with Partner Groups such as GES ( Global Engineering Services), Facilities Management (FM/GWES) and Original Equipment Manufacturers ... (OEM) and vendors.Provide engineering and quality engineering (QE) support, ensuring facility, utilities and equipment... Management System (QMS) activities.- Interface with site & global engineering and maintenance groups, as well as outside… more
- Merck & Co. (North Wales, PA)
- …leadership, technical skills, and scientific acumen as part of a global , cross functional team.Job ResponsibilitiesResponsible for leading specific aspects of ... study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment… more
- Merck & Co. (Durham, NC)
- … compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control).- ... of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing development and… more
- Merck & Co. (North Wales, PA)
- …of medical drugs and vaccines for the benefit of patients and global human health.The Associate Vice President (AVP), Late Development Statistics, BARDS, is ... will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction through senior-level… more
- Merck & Co. (Rahway, NJ)
- …your leadership, technical skills, and scientific acumen as part of a global , cross-functional team . - Job Responsibilities - Responsible for leading specific ... (e . g . , ICF documents/ amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data collection in alignment with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the...of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well ... candidate will be commensurate with experience. Relationships Reports to: Manager , Process Support (Downstream) Essential Functions Assist with coordinating… more
