- Insmed Incorporated (Bridgewater, NJ)
- …but not necessarily be limited to, the following: Responsible for final product Quality release/rejection and related processes.Partner with other Regional ... Design Control Process for medical device products and combination products.Lead the quality assessment for product lifecycle changes, efficiency projects, and… more
- Merck & Co. (North Wales, PA)
- …Health External Manufacturing groups and associated functional areas related to the Product Quality Complaint (PQC) system. They also support the Management ... Job DescriptionThe Senior Specialist, Quality Management Systems and...team colleagues with all aspects of the Animal Health Product Quality Complaint (PQC) business process including… more
- Merck & Co. (Durham, NC)
- …and embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. - The Senior Specialist for ... Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior ...system(s) to ensure a compliant, reliable supply of the product and on-time project execution. Provide production shop floor… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …registrational studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and ... to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across various topics, such as clinical trial management, deviation handling, and product quality Develop, execute, and maintain sufficient training to support ... with the FDA to providing medical education and collecting data to support efficacy and new product ...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (North Wales, PA)
- …ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical ... programming point of contact and knowledge holder through the entire product lifecycle. Primary Activities :Effective analysis and report programming development and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and executing post-approval Regulatory CMC strategies, reviewing CMC information and data , authoring CMC submissions, and interacting with Health Authorities to meet ... Supplements (PAS, CBE-0, CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... 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… more
- Tris Pharma (Monmouth Junction, NJ)
- …supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls ... Corrective and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, … more
- Catalent (Harman, WV)
- …, audits and inspections, raw materials release, and compiling, trending and reporting key quality metrics for Senior Management review, and other quality ... Position Summary The Director, Quality Systems is responsible for the management and...report via a PowerPoint presentation to be reviewed by Senior Management on a periodic basis. Track action items… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director/ Senior Director, the Principal Scientist /Director is responsible for developing and implementing ... and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and… more
- Novo Nordisk Inc. (Chicago, IL)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....to make a difference? Open to hiring at the senior level commensurate with experience. The Position Builds relationships… more
- Novo Nordisk Inc. (Tacoma, WA)
- …care, understanding the local market and customer needs and positioning Novo Nordisks product and services to improve care of patients with obesity to maximize sales ... sales strategies aimed at effectively selling and promoting Novo Nordisk product (s) to physicians, pharmacists, nurses, other paramedical customers, employers and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all vendor managed business setups with the objective of achieving the highest data quality standards, full adherence to patient's rights and well-being and ... GCP strategic discussions.Support the Head of RD QA with Quality Reviews of respective product profile to...groups and respective CROs in order to ensure high data quality and proactive detection and resolution… more
- Merck & Co. (Rahway, NJ)
- …adoption of new digital capabilities that allow for better access to high-fidelity data , more efficient clinical product release, improved product /process ... Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being...the Enterprise Resource Planning systems (SAP, PAS-x) and the Data Analytics output of those areas. -The RY119, RY53… more
- Merck & Co. (Rahway, NJ)
- …efficient and seamless access to relevant information across multiple systems and platforms.Establish data quality control processes to ensure data accuracy, ... value team in Our Company's R&D IT brings together product management, engineering, and data science expertise...databases (eg, Cancer Genome Atlas).Stay informed about the availability, quality , and limitations of various data sources… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's ... together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....works closely with associate directors, directors, VPs, and other senior leadership across the organization, including Legal, Finance, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....and field alignment directors. They will also be the senior strategic representative of medical affairs in the relevant… more
