- Merck & Co. (Upper Gwynedd, PA)
- …high- quality data from clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head of Clinical ... Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)}...include ongoing partnership with the Research & Development Division Quality Assurance (QA) and acting as the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality ... supplies across the DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations ) Project Lead is primarily responsible for developing and updating… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , ... Compliance standards. Key Relationships: Works in a collaborative team setting with quality counterparts that include Manufacturing Operations , Quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , ... a QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New...cell therapy.A minimum of 2 years of experience with quality support in clinical manufacture is preferred.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research, Research, ... the US, EU, Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a collaborative team setting with quality counterparts that include Quality Assurance , Manufacturing Operations , Technical Operations , Engineering ... Biotech is seeking QC Supervisor as part of the Quality Operations team based in Raritan, NJ....experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance , or… more
- Merck & Co. (Durham, NC)
- …pharmaceutical manufacturing industry, specifically in pharmaceutical operations , technical operations , validation and/or process Quality Assurance . - ... Job DescriptionSenior Specialist, Quality Systems and Compliance (P3) Our company is...BOM changes and Master Batch Records. Review and approve Operations , Technology, or Automation protocols. Leads or actively participates… more
- Novo Nordisk Inc. (Boulder, CO)
- …Quality Assurance / Control, Chemical Development, Program Management, Regulatory, Quality Control, Supply Chain, and Clinical Write, review, and/or ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and process qualification, packaging and labeling. This position will interface with Operations , Regulatory, Quality Assurance , Finance, R&D, Project ... coach cross functional team staff in areas such as quality , compliance, safety, project planning, process development, technology development.Communicate effectively… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , ... and complaint product supply.Key ResponsibilitiesSupport compliance activities for site Quality Operations in accordance with Legend standards, procedures and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research, Research, ... the US, EU, Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing complianceKnowledge of cGMP regulations and ... Plans, and Annual Product ReviewsWorks in a collaborative team setting with Quality , Manufacturing Operations , Facilities & Engineering Quality Control,… more
- Christus Health (Tyler, TX)
- …operational and technical requirements. Independently provides guidance and leadership on quality assurance and testing initiatives. Demonstrates ability to lead ... recommendations and practice. Applies advanced level understanding of assigned clinical /business operations , processes, and workflows. Discusses, and identifies… more
- Christus Health (San Antonio, TX)
- …customer service, leadership, and displays a positive attitude * Responsible for Quality Assurance testing as required by regulatory agencies and/or Manufacture ... This position provides leadership and direction to the daily operations of their clinical area. This leader...clinical area. This leader ensures the delivery of high- quality images and services consistent with the core values… more
- CenterWell (Charlotte, NC)
- …15+ employees, highly preferred. + Strong background in home health clinical operations and quality assurance , highly preferred. + Experience supporting ... personnel. + Develops, plans, implements, analyzes, and organizes clinical operations for a specific location managed....clinicians to promote more effective performance and delivery of quality home care services, and is available at all… more
- System One (Florham Park, NJ)
- …work collaboratively with cross-functional teams, including regulatory affairs, clinical operations , and quality assurance in a team?oriented ... Senior Regulatory Operations Associate Contractor (Publishing) Must be local for...experience in preparing and submitting regulatory documents, including nonclinical, clinical , CMC, DMF, and labeling/SPL., in eCTD format. +… more
- Dartmouth Health (Lebanon, NH)
- …of research operations , including Pre-Award, Regulatory Compliance, Clinical Operations Support, and Quality Assurance . Ensure seamless coordination ... professional development and growth within your teams. * Compliance and Quality Assurance :Maintain rigorous compliance with state and federal regulations,… more
- Astellas Pharma (Northbrook, IL)
- …across Early Development Clinical Operations , the asset teams, and Clinical Quality Assurance , to ensure strategic oversight and implementation of ... to support site management strategic planning + Works with Internal Audit and Quality Assurance stakeholders to define QA/audit needs for site audits globally,… more
- AbbVie (North Chicago, IL)
- …industry experience in GCP quality assurance or regulatory affairs or clinical development or clinical operations + Prefer 1+ years of GCP ... YouTube and LinkedIn. Job Description The Program Manager - Clinical Quality Assurance is primarily... Operations organization and supporting functions to ensure quality compliance across all aspects of clinical … more
- United Therapeutics (Silver Spring, MD)
- …at our Silver Spring, MD office and 2 days/week work from home. + Develop Clinical Quality Assurance (CQA) Standard Operating Procedures and policies and ... role is responsible for the management and execution of clinical quality oversight activities in support of...2+ years in a clinical process or operations role + Certified Quality Manager (CQM)-ASQ… more
