- Insmed Incorporated (Bridgewater, NJ)
- …knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance .Commercial drug manufacturing site QA head experience ... in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality … more
- Insmed Incorporated (Bridgewater, NJ)
- …Executive Director of Development Quality Assurance , the Senior Director of Pharmacovigilance QA serves as a strategic partner managing quality ... to, the following:Facilitate and maintain a risk-based and scientific-based quality system to support Good Pharmacovigilance Practice (GVP).Establish and maintain… more
- Catalent (San Diego, CA)
- Job Title: Quality Assurance Associate, Analytical City: San Diego State : CA JOB DESCRIPTION:Review of analytical release and stability data, involving review ... external audits.Lead or support client audits along with the Director and Associate Director of Quality...equipment.Point person for safety complaints and improvements in the Quality Assurance Department using the Intelex software… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …approvals. Lead in a proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for all GxP matters for ... Program Head and the Global Program Team. Provide operational QA leadership for the respective GPTs, including Quality... QA leadership for the respective GPTs, including Quality Oversight for the Quality Plan execution,… more
- Aequor (Seattle, WA)
- …independent, great communication Experience working cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist ... for the site. Generate document management system reports for Quality Council metric reporting. Support internal and external audits... principles Position Reports to Jenna Walker - Associate Director , QA Training & Document Control Education:… more
- Catalent (Philadelphia, PA)
- …Control, and Customer relations.The Role: Provides direction and guidance to the Quality Disposition, Materials Sampling Quality Assurance , Regulatory and ... Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality...Compliance Quality Assurance , and Validation Quality Assurance . Management responsibilities include professional development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …compliance risks and operational support, in conjunction with key stakeholders (Legal, Compliance, Quality Assurance ( QA ) and Medical Affairs Subject Matter ... CoE Risk Management Plan (RMP) and operational oversight:In partnership with QA and other relevant stakeholders across line functions, geographies and levels… more
- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond to ... is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …of internal customers such as Project Management, Site Operations, Validation, and Quality Assurance to properly identify design needs of multiple simultaneous ... Position Summary The Engineering Director is directly responsible for leading the Engineering team in the successful design, construction, and commissioning of… more
- Eisai, Inc (Exton, PA)
- …assays, designing future studies, overseeing assay validation and interacting with QA to determine product stability and shelf life. Since these programs ... are for products from pre-IND through phase 3, knowledge of the regulatory requirements at each stage of clinical development is essential.This position will have a direct impact on the success of the company by managing the analytical testing for several… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relationships with internal and external stakeholders. Coordinate with lab units, SC, RACMC, QA to drive collaboration and solves issues in Tech Mgmt. (mAb, Drug ... Substance, Drug Product, or New Modality) team.- Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses to regulatory questions, briefing books. Qualifications: Successful… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …teams, and supports change implementation. Coordinates with regional/global RACMC, Quality Assurance , Pharmaceutical Technology, and other functional areas ... areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA , as appropriate. Support and/or lead identification ... centered around rare diseases and immune disorders. Summary The Associate Director , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support… more
- Executive Alliance (Cypress, CA)
- Our client is seeking a talented and driven Director of Quality Assurance to join our team. In this role, you will be responsible for consistently improving ... overall quality and maintaining a Quality Management System (QMS), keeping up with an evolving product line, and changing customer requirements. Job… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require ... primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …position that will be responsible for administrative and instructional duties. The EMS Quality Assurance Coordinator is responsible under the direction of the ... Director of EMS and EMS Medical Director for ensuring the operational quality and continuous clinical improvement of EMS services that are provided by the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …US sales force including registration, investigation and implementation of corrective actions Quality Assurance : Provides secondary support to all NN GxP Support ... and/or in collaboration with global colleagues. Relationships Reports to the Associate Director Product Quality . Regularly interfaces with multiple NN Quality… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... portfolio for all products, and writing and maintaining regulatory documentation. Relationships Director . Essential Functions Lead, drive & coach teams to ensure a… more
- Novo Nordisk Inc. (Boulder, CO)
- …& other stakeholders, & presentation in steering groups Support local Quality Assurance unit activities Business Process Improvements: Manage activities ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA , as appropriate.-Participate with the identification ... and assessment status. In addition, this role will support the FxExc Director in lead innovation and optimization by gathering industry expertise and trending… more
