- Novo Nordisk Inc. (Durham, NC)
- …4:00 pm - 2:30am with the ability to train on Days. Relationships Manager, Quality Assurance . Essential Functions Ensure plant systems batch release & relevant ... field from an accredited college with a minimum of seven (7) years of experience in QA or related quality experience May consider a High School Diploma or GED… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …Will be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing and support records to ... and procedures Releases product based on Quality Assurance record review and approval by QA ...Performs regular internal audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality… more
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in Life Sciences or Engineering.Minimum of 4+ years' experience in Quality Assurance Biotech/Pharmaceutical industry experience. Knowledge of cGMP regulations ... is seeking a QA Batch Disposition Specialist as part of the Quality team based in Raritan, NJ. Role OverviewThis exempt-level position is responsible for… more
- Genmab (Plainsboro, NJ)
- …or the US. Main responsibilities include:Provide QA leadership to the global Quality Assurance team at Genmab.Strengthen and develop the QA ... QA organization, manage resources, and ensure compliance with quality standards.In this role, you will lead ...or health-related field.Minimum of 15 years of experience in Quality Assurance across all GxP related areas… 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …a passion for results and company performance.Must set the expectation for the company in quality mindfulness and lead by example. Must be able to sit and/or ... Position SummaryThe Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position is… 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
- Insmed Incorporated (San Diego, CA)
- …in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance , Medical Affairs, Marketing, Manufacturing, and Legal. Leads ... and Best Medium Workplaces™ lists.OverviewThe Senior Director, DSPV Gene Therapy Safety Lead will be the safety expert for Insmed's gene therapy products and… 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …plans for staffAssist in the performance of Media Fills with input from Quality Assurance , Validations, and Operations This position may be involved with ... Position SummaryThe QC Microbiology Group Lead will report directly to Microbiology management, (ie,...leadership in building, leading and developing a group of quality control microbiologists that support the ongoing development, manufacture,… 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
- Tris Pharma (Monmouth Junction, NJ)
- …regulatory requirements and guidelines for clinical trialsExperience with data management and quality assurance processesAbility to potentially lead and ... This is an individual contributor role with potential to lead and manage a small team in the future....for clinical trialsHands on experience with data management and quality assurance processesExperience interacting with FDA and… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …closely with Engineering, Manufacturing, Facilities, Manufacturing Sciences & Analytical Technology, Quality Assurance , Quality Control, and Validation, on ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...and leveraging available resources to deliver assigned project objectives. Lead efforts to analyze "as is" state, make recommendations… 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)
- …& 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance , Finance, R&D, Project Management and Quality ... to complete the technology transfer for customers. This position will lead , mentor and grow the Technical Service Department.Job ResponsibilitiesFunction as the… more
- Genmab (Plainsboro, NJ)
- …delivery of year end annual awards trip and promotion criteria based on performance.Manage quality controls and quality assurance in the tracking & ... processing.Proactively monitors and strives to maintain high levels of quality , accuracy, and process consistency in field incentive compensation planning… more
