- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in ... Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems processes within… more
- Merck & Co. (Rahway, NJ)
- …set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both clinical and ... particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be… more
- Repligen (Hopkinton, IA)
- OverviewThe Manufacturing Line Lead 2nd Shift reports to the Production Manager and helps in performing all tasks involved in the production of Repligen's fluid ... will play a key role in ensuring that the department's safety, quality , and production goals are met.ResponsibilitiesSupervise and coordinate the activities of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position Developing quality and strategic objectives and strong business understanding of...chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to ... applicable Develops comprehensive, relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across NNI and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position Developing quality and strategic objectives and strong business understanding of...chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- BioAgilytix (Durham, NC)
- …a foundational data governance framework, with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build ... with a focus on operational efficiency and data integrity. Data Quality & Compliance Automation: Use Robotic Process Automation (RPA) tools like UiPath or… more
- Insmed Incorporated (San Diego, CA)
- …managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other ... cross functional working groups to identify and mitigate GCP quality and compliance issues.Supports the evaluation and acceptability of vendors for potential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role… more
- Repligen (Waltham, MA)
- …audit schedules; serve as host for site auditsMaintain risk-based strategy for overall Quality compliance across the organization and in support of the ISO ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology… more
- Syneos Health Careers (Morrisville, NC)
- …- Clinical Monitoring Excellence (Remote, 75% Travel, East & West Coast Roles) Elevate Quality . Drive Compliance . Lead with Integrity. Are you a seasoned ... Description Quality and Compliance Assessor - Clinical...in root cause analysis-you don't just identify problems, you lead solutions. Courageous and objective-you won't sugarcoat poor outcomes… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …strict adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This position carries ... your potential? The Position This position has primary responsibility to support Quality Control operations in the microbiology, analytical or inspection area. This… more
- Merck & Co. (Rahway, NJ)
- …launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership ... of team members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance:Ensure that all activities are conducted… more
- Novo Nordisk Inc. (Durham, NC)
- …improvement, & project management Serve as the Lead and SME to operate within compliance with a quality mindset that focuses on risk management & mitigation ... us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical...team's Change Management standards and always manage assignments within compliance with a Quality Mindset that focuses… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Durham, NC)
- …leadership skills to empower teams, solve complex technical challenges, and ensure compliance with industry standards while making a tangible impact on our ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… more
- Merck & Co. (Rahway, NJ)
- …The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The ... and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE) support, ensuring facility, utilities and equipment are… more
- Merck & Co. (Durham, NC)
- …routine internal and external GMP and Financial audits, QSAT actions, to ensure compliance .- This is a fast-paced and multi-faceted role that provides leadership and ... external GMP and Financial audits, input to QSAT actions, to ensure compliance .Support the Master Data team with general Material Handling Steward tasksDrive safety,… more
- Merck & Co. (Rahway, NJ)
- …Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance , Management Process, Manufacturing Quality Control, Medical Supply ... its' Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the… more
