- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for ... trials. Establish and maintain 'fit for purpose' GMP related quality assurance procedures processes, and documentation to...outside of QA . Assure the execution of QA Audit Plans, Lead internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the Global RD/PV QA team.RESPONSIBLITIESProgram oversight: Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs) by ... a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality...the delivery and execution of non-project initiatives within R&D Quality and Global RD/PV QA by collaborating… more
- 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
- 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)
- …areas centered around rare diseases and immune disorders. SummaryAccountable to lead , manage and ensure that all Contract Manufacturing, Testing and Warehousing ... internal DS policies, procedures or standards. The incumbent is responsible to identify QA risks at CMO's and support the recommended courses of risk treatment and… 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 ... and more efficiently.About the PositionWe are seeking a seasoned Staff Engineer to lead our AI Foundations Team-a new initiative dedicated to establishing the core… 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 ... updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation of… 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 ... that deliverables are met according to agreed timelines and quality standards. Lead a team of professionals specializing in intelligent automation, solution… more
- Tris Pharma (Monmouth Junction, NJ)
- …Summary:The Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance ( QA ) Investigations and Product Quality ... Improvements (CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Leadership:Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including ... Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program...of the operations lead of study team lead . Coordinate and liaise with Daiichi Sankyo QA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary The purpose of this job is to lead certain pipeline support activities and assist in the identification, coordination assessment, ... proposal/review/negotiation of EOI/NBTS and Definitive Agreements, either acting as Lead for simple opportunities or supporting more complex transactions. Work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the ... but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA , Reg CMC, and IT. This individual will support electronic batch record… more
- Englewood Lab, Inc (Totowa, NJ)
- Title: Quality Assurance ( QA ) Lead - Documentation and Product Release Reports to: Quality Assurance Supervisor or Manager Department: Quality ... and Device History Reviews. + Oversee and maintain the Quality modules in the ERP system for compliance (Change...and provide corrective and preventive actions with follow-ups). + Lead the review, release of compliance materials (eg FG,… more
- Englewood Lab, Inc (Totowa, NJ)
- Title: Quality Assurance ( QA ) Supervisor Reports to: Quality Manager or Head of Quality Department: Quality Assurance Responsibilities: + ... batch release personnel, accurate record of approved, quarantined, rejected products. + Lead the review, release and compliance of materials, FG, bulk and… more
- Meta (New York, NY)
- …with adherence to policies, procedures, and regulatory expectations. **Required Skills:** Compliance Quality Assurance Lead Responsibilities: 1. Build and ... is to support Meta FinTech Compliance (MFTC) with the quality assurance of complex investigations performed by...insights, including repeated patterns, coaching opportunities and metrics to QA management and FIU team leads 6. Apply analytic… more
- FreshRealm (Linden, NJ)
- …Before a product is released to the public, it goes through a lot of quality assurance testing: the QA Lead organizes and manages that testing. The QA ... Quality Assurance - IDL - Team Lead ...make employment decisions based on merit.** **General Job Description** ** QA Lead is responsible for leading their… more
- TD Bank (New York, NY)
- …management system) to optimize the efficiency and accuracy of analyst alert reviews. * Lead Quality Assurance Reviews & Drive Improvement Conduct regular ... on us. Job Description The Global Head of Surveillance Quality Assurance will lead a...advanced surveillance tools, this role will enhance existing surveillance quality assurance ( QA ) program and… more
- MUFG (New York, NY)
- …+ Assist Global Head of QA with the development of a risk-based quality assurance plan for assessing audit activities in Americas and EMEA regions. + ... Lead a team of 3-5 to execute the quality assurance plan, performing reviews of internal...QA projects concurrently across regions, ensuring delivery of high- quality work within designated timeframes and budgets. + Develop… more
- Sanofi Group (Ridgefield, NJ)
- **Job title** : Quality Assurance Shop Floor Lead **Location:** Ridgefield, NJ **About the Job** We deliver 4.3 billion healthcare solutions to people every ... hope to patients and their families. Your job, as Quality Assurance Shop Floor Lead ...floor program and address concerns with manufacturing and driving quality improvements + Mentoring and coaching QA … more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: The Group Leader, QA will lead , schedule and coordinate daily priorities for incoming raw materials sampling, release, reject, hold and ... inspection/in process QA Support/Packaging/Auditing activities in manufacturing and packaging areas. The group leader QA will train, coach and mentor QA … more
