- Merck & Co. (Millsboro, DE)
- Job DescriptionThe Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) ... Biopharmaceutics, Corrective and Preventive Action (CAPA), Detail-Oriented, Driving Continuous Improvement , GMP Compliance , Manufacturing, Pharmaceutical Quality… more
- Eisai, Inc (Nutley, NJ)
- …clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in Clinical Quality /CQA conducting a ... week#LI-CCEisai Salary Transparency Language:The base salary range for the Senior Director , Clinical Quality Assurance is from :236,900-310,900Under current… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Key Quality Indicators (KQIs). Identify and drive initiatives for continuous quality improvement .Deputize for the Sr. Director , Medical Affairs QA ... and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director...Quality Standards in Medical Affairs and identify continuous improvement opportunities in quality and compliance… more
- Repligen (Waltham, MA)
- …- Quality Network Leader, Chromatography & Proteins.ResponsibilitiesThe Director , Quality will be responsible for:Maintaining site compliance to ISO 9001 ... OverviewWe are seeking an experienced Director of Quality candidate to lead...as host for site auditsMaintain risk-based strategy for overall Quality compliance across the organization and in… more
- Merck & Co. (Rahway, NJ)
- …packaging and assembly equipment standards, technical lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of ... Material(s):n/aRequired Skills:Applied Engineering, Applied Engineering, Change Management, Combination Products, Compliance Packaging, Continual Improvement Process, Cross-Cultural Awareness,… more
- Merck & Co. (Rahway, NJ)
- …provide support to life cycle changes, investigations, trouble shooting and continuous improvement initiatives to guarantee the robustness and compliance of our ... Skills:Applied Mathematics, Applied Mathematics, Business, Client-Focused, Client Relationship Building, Compliance Packaging, Confidentiality, Continual Improvement Process, Driving… more
- Merck & Co. (Rahway, NJ)
- …Management Process, Manufacturing Compliance , Medical Devices, Product Commercialization, Quality Management System Improvement , Regulatory Compliance , ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership...launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE the Director ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures ... the material content of any documents sent to regulatory authorities. Provides compliance metrics to management, as needed.Lead continuous improvement around… more
- Merck & Co. (Durham, NC)
- …is seeking a highly motivated individual for the role of Assoc. Director , Engineering.- This role will provide end-to-end support of manufacturing science and ... products including Drug Substance, Drug Product, and Analytics.-We are seeking an Assoc. Director to join our Live Virus Vaccine (LVV) team. The successful candidate… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (ED) for US Medical Affairs (USMA) understands Our Company's enterprise level strategies and leads cross-functionally with the ... for the US, including tactical execution by the field Regional Medical Scientific Director (RMSD) teams and is accountable for ensuring field teams execute on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position working...multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.- Ensures ... to database release, data review and cleaning, database lock), to ensure data quality /integrity and regulatory compliance - Ensures that Data Management Plans are… more
- Insmed Incorporated (San Diego, CA)
- …and implementation of EDC systems to support clinical trials, ensuring data quality , compliance , and efficiency throughout the study lifecycle. The AD, ... solutions comply with GCP, 21 CFR Part 11, and CDISC ODM StandardsData Quality & Compliance :Ensure EDC systems comply with regulatory requirements (eg, FDA,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …would provide reduction in COGs, and increase throughput, capacity, and quality compliance .Work cross-functionally across the organization and interface with ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Manufacturing Execution System as part of the Global MSAT team based… more
- Merck & Co. (North Wales, PA)
- …supply of commercialized products for the benefit of patients. The Associate Director of Equipment Engineering is integral to this mission. The successful candidate ... packaging process and equipment issues, optimizing processes, and ensuring compliance . Effective collaboration with site-based and above-site based functional teams… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Associate Director within Metrics, Analytics & Performance (MAP) has experience in clinical operations and is responsible for leading the ... SDLCManaging diverse projects and processes within GCTO/MAP Teams.Champion data quality , integrity, and reliability by designing and promoting best practices.Bridge… more
- Merck & Co. (Rahway, NJ)
- …and regulatory compliance such as ADA, environmental, and building codes.Ensure quality control over planning of a legible and safe environment of high- ... campus planning?- Have you advised on design standards, project scope, and regulatory compliance as well as act as a liaison with internal department stakeholders… more
- Merck & Co. (Millsboro, DE)
- …leaders and frontline teams, and who works effectively across functional partners. Quality - and compliance -focused with practical experience supporting regulatory ... Freeze Dry, Good Manufacturing Practices (GMP), Lean Six Sigma Process Improvement , Management Process, Manufacturing Quality Control, Motivating People,… more
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