- Formation Bio (New York, NY)
- …EMA), industry standards (eg, cGMP), and company policies. Establish and maintain quality assurance procedures, processes, and documentation to ensure the ... of changes in regulations, guidelines, and industry trends related to pharmaceutical quality assurance and proactively implement necessary updates to the QMS.… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for ... availability for trials. Establish and maintain 'fit for purpose' GMP related quality assurance procedures processes, and documentation to ensure the consistent… more
- Formation Bio (New York, NY)
- …performance. Collaborate with cross-functional teams-Tech, Data Science, Regulatory, and Quality Assurance -to translate strategic requirements into innovative ... technical solutions. Innovation & Cross-Functional Collaboration: Stay current with emerging trends and technologies in AI infrastructure and platform engineering to identify new technical investments and opportunities to enhance our AI capabilities. Act as an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SUMMARYProvide support to the Global and Regional Quality Leads, External Partner Quality Leads, and Business Partner ... on assigned programs and in close collaboration with R&D Quality team members to ensure that the organization is...a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads… more
- Tris Pharma (Monmouth Junction, NJ)
- …Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team ... needs and activities in to accurately, effectively, timely and compliantly achieve quality goals and key performance metrics across multiple quality functions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …organization working closely with local, regional and global stakeholders across the Quality Assurance organization and with members from different business ... Director, GMP QA Process Excellence is accountable to collect information, analyze quality related process, define strategies to lead to the development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities, and supporting complaint and recall programs. This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well ... expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality… 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 ... Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.Vendor Management… more
- Tris Pharma (Monmouth Junction, NJ)
- …and guidelines for clinical trialsHands on experience with data management and quality assurance processesExperience interacting with FDA and other regulatory ... requirements and guidelines for clinical trialsExperience with data management and quality assurance processesAbility to potentially lead and develop a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in support of site improvement projects and strategies.Be a Subject Matter Expert on quality assurance topics within the group in support of QC lab ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …testing strategies and processes to ensure all systems and solutions meet the required quality standards, collaborate with quality assurance teams to ensure ... to ensure that deliverables are met according to agreed timelines and quality standards. Lead a team of professionals specializing in intelligent automation,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , quality control, manufacturing compliance, clinical ... a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...is an exempt level position with responsibilities for providing quality oversight over the compliance program for the site… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …must have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... Legend Biotech is seeking QA Investigations Supervisor as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigations Supervisor has the… 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 ... outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any required… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... Document Control Specialist (1st Shift) as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...tasks in a manner consistent with the safety policies, quality systems and cGMP requirementsReview and approve SOPs, and… more
- Tris Pharma (Monmouth Junction, NJ)
- …FDA requirements Performs packaging line change overs and startups Assists Packaging Operations/ Quality Assurance (QA) activity during the running of packaging ... lines Performs routine and complex work related to the troubleshooting, repair, and upgrade of all packaging equipment including but not limited to: fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc. Responsible for performing PM, repair… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance.Expertise in GMP compliance ... knowledge including knowledge of 21 CFR Part 11, EU Annex 11 among othersExperience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.Thorough knowledge and understanding of GMP data integrity standardsKnowledge of cGMP… more
- Breaking Ground (New York, NY)
- Quality Assurance Analyst, HMIS 505 8th Ave, New York, NY 10018, USA Req #2948 Monday, February 24, 2025 ABOUT US: - We believe that everyone deserves a home! ... contracts, and overseeing Breaking Ground's data collection and analytics, and quality assurance efforts. This department plays an integral role in Breaking… more
- TD Bank (New York, NY)
- …Compliance team is seeking a Director level Global Head of Surveillance Quality Assurance . Department Overview Our team of trusted Surveillance Compliance ... depends on us. Job Description The Global Head of Surveillance Quality Assurance will lead a specialized function responsible for evaluating the effectiveness… more
- Project Renewal, Inc. (New York, NY)
- Senior Director, Program Evaluation and Quality Assurance Program Evaluation and Quality Assurance - Varick, 200 Varick St, New York, New York, United ... February 11, 2025 Title: Director of Performance Evaluation and Management & Quality Assurance Salary:$126,000 Program Overview: The Program Evaluation and … more
