- Merck & Co. (Rahway, NJ)
- …rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical ... new drugs and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with compliance and Program Management team on build and design of programs Expert in identifying and reporting adverse events, product technical complaints and ... us? The Position The Associate Director will be the lead who is responsible for ensuring that all aspects...responsible for ensuring that all aspects of our patient quality and safety operations meets standards. This position requires… more
- AUROBINDO (Durham, NC)
- …experienced team members. Seeks proactive support and coaching from the Project Leader , Scientific Expert , or other team members if necessary.Provide ... of companies with a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10-year history of extraordinary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc ... milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes Process Best Practices:… more
- Merck & Co. (Rahway, NJ)
- …Director, RMSD, is a credentialed (ie, MD, PhD, or PharmD) therapeutic and disease expert who engages in scientific exchange with leaders in the external medical and ... does not include promotional claims about any drug, vaccine or biologic product . RMSDs provide to Scientific Leaders (SLs) balanced, factual, scientific information… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member ... milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes Process Best Practices:… more
- Merck & Co. (Rahway, NJ)
- …leverages significant depth and breadth of scientific/technical experience to: (i) lead and contribute to assigned late-stage Active Pharmaceutical Ingredient (API) ... mentor junior staff within the CCT organization, and (iii) lead or support internal and external development with line...small molecule process characterization work by learning and utilizing Quality Risk Management (QRM) / Quality by Design… more
- Merck & Co. (Durham, NC)
- …documentation associated with the development and implementation of assays for product release, quality lab qualifications and method verification efforts ... Shopfloor Analytical Technical Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for… more
- Merck & Co. (Rahway, NJ)
- …methods all in a GMP environmentKnowledge and experience with manufacturing and product testingExperience in leading and supporting quality investigations and ... .Track-record of independent problem-solving.Applying microbiology expertise as a subject matter expert for quality controlInteracting with internal and external… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Utilities as well as closely monitoring the existing systems with respect to quality of final product and efficiency of operation. Responsibilities will ... Utilities), you will provide cross-functional support to operations, maintenance, quality and project teams for site GMP utilities. You...as needed. This role is the site Subject Matter Expert (SME) for site GMP Clean Utilities infrastructure and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …track record delivering results Proven track record in HCP marketing and product launches strongly preferred Expert understanding of the pharmaceutical industry ... within their designated Hemophilia Therapy Area and for relevant in-line and new product commercialization assets (3 years prior to launch). They will lead … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and ... operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs)....on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… 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 ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...Relationships Reports to: Manager of Automation Engineering Essential Functions Lead , plan, organize and coordinate the execution of projects… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and peers.Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality /Manufacturing personnel.Independently makes appropriate ... Quality risk assessment teams.Review/approve documents as a Quality on the Floor Subject Matter Expert ...directly supervising employees is preferred.Ability to work with and lead others in a team environment.Demonstrated ability to develop… more
- Twist BioScience (South San Francisco, CA)
- …and implement robust APIs, web services, and backend systems. Collaborate with product managers, designers, other engineering teams, partners on B2B integrations to ... define project requirements and deliver high- quality solutions. Participate in requirements gathering, technical specification, design, and development of software… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationship with key stakeholders and senior management within Finance, Legal, IT, Quality , Compliance and Product Safety. Leads an Operations team comprising ... Process Leadership and Continuous Improvement: Collaborates with the Operations Senior Leader on the development of the vision, strategic priorities, and roadmap… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partner companies. Responsible for development and maintenance of a PVA repository Lead development of contract templates in cooperation with Legal Department and PV ... these contracts. Organize and conduct periodic review of contract quality and adherence. Support business functions in determining PV...and organize transfer of PV Business in case of Product Divestment Collaborate with DSI audit groups to ensure… more
- Volvo Group (Hagerstown, MD)
- Expert Product Quality Leader Location: Hagerstown, MD, US, 21742Greensboro, NC, US, 27409 Position Type: Professional Transport is at the core of modern ... investigating and prioritizing market product quality issues. As an Expert Product Quality Leader (PQL) you will secure the voice of the customer… more
- Chewy (Bellevue, WA)
- …for non-conforming issues for internal facilities and suppliers + Act as subject matter expert for product quality , safety and regulatory within owned ... of the Customer, is data driven/analytical, can develop deep insights, and take the lead to drive continuous improvement of quality for our consumable products… more
- Integra LifeSciences (Boston, MA)
- …new standards of care. The Staff Quality Engineer is a subject matter expert responsible for providing product quality and engineering leadership focused ... Post-Market Surveillance groups to ensure a high level of product quality and effective and efficient investigations...subject matter expert with extensive knowledge of quality engineering. They lead moderate to significant… more
