- Merck & Co. (Durham, NC)
- Job Description- The Associate Director of Quality Systems provides leadership, focus, and governance to the Hilleman site in the following Quality Systems: ... Deviation Management, Complaints, Corrective Action/Preventive Action Management, Annual Product Review Authoring, Quality Risk Management, and Quality … more
- Merck & Co. (North Wales, PA)
- …execution for successful delivery across various teams and vendor partners to meet product line objectives with high quality , timeliness, and within budget / ... drives results.Reporting to the HH IT US Data Services Product Line Leader, this role will be responsible for...data products. The role influences and ensures timely and high- quality value delivery across all aspects of the data… more
- Merck & Co. (Rahway, NJ)
- …the Position The Animal Health IT Customer Master Data Management (MDM) Product Owner collaborates with stakeholders across all levels of the organization, from ... that balances user desires with technology capabilities.Develop and maintain product materials, including training documentation, SDLC documentation, and product… more
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , Quality Assurance - Analytical,GMP has responsibility for the ... approval of GMP analytical records. Will also provide QA support for GTx Quality Control laboratories. This position is onsite/hybrid and based in San Diego,… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, and… more
- Fidelity TalentSource LLC (Boston, MA)
- Job Description:The RoleThe Director , Investment Product will be responsible for managing and leading due diligence efforts associated with Fidelity s ... of Fidelity s alternatives initiatives.Creating and enhancing investment content for product positioning in collaboration with investment teams and marketing. The… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team resources, issues, risks as well as achieving overall project level quality metrics. An ideal Associate Director , Program Management must have ... centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for effectively planning,… more
- Merck & Co. (Rahway, NJ)
- …process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for proactive ... talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and safety.NOTICE FOR INTERNAL… more
- Merck & Co. (Rahway, NJ)
- …development and GMP clinical supply manufacture of our Company's drug product pipeline.- The FLEx Process Engineering Lead drives process development expertise, ... formulators and device engineers to develop robust and innovative drug product manufacturing processes.- Close partnership with colleagues from Formulation Sciences,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Business Systems and Process Improvement leads procurement efficiency and continuous improvement initiatives within Animal Health ... like RPA, Celonis, and AERA. Reporting to the Vice President of AH-GSM, the Director is a key member of the leadership team driving digital transformation withing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new ... and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal stakeholders… more
- Eisai, Inc (Nutley, NJ)
- …Summary The Director is responsible for developing strategies for assigned product (s) and execution of HEOR and RWE research for the development and ... communication of product value data to support Eisai business. This role...research activities and development of external communication materials. The Director facilitates coverage, reimbursement and appropriate utilization based on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... Supplements (PAS, CBE-0, CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Job Summary: The Director , Diagnostic Sciences will be responsible for end-to-end process for CDx ... forms, scoring forms, and DTS documentsDevelops and implements a testing quality monitoring program, ensures consistent data monitoring and output across the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process is maintained in a validated and controlled state and consistently delivers quality product meeting or exceeding the standard of various health ... in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical...participation in a variety of cross functional CMC and quality forum under the Joint Manufacturing Committee in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes Process Best Practices: ... serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise ... plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions… more
- Eisai, Inc (Nutley, NJ)
- …and make a difference. If this is your profile, we want to hear from you. Director , Global RWE & Data Science sought by a pharmaceutical company in Nutley, NJ. Assess ... initiatives that address issues such as payer challenges, impairments in quality of life and patient well-being, and gaps in clinical practice.Requirements:Master's… more
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