- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance, industry competitiveness and operational excellence Oversight of performance management : Facilitates regularly scheduled call quality calibrations, ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with a focus on corporate functions (eg, Procurement; Real Estate; Digital, Data and IT; Finance and Tax) and complex and high-risk supplier contracting. ... Provide Strategic Legal Counsel Interpret complex internal and external business issues related to contracting and recommend best practices and solutions Proactively… more
- Formation Bio (New York, NY)
- …the product development lifecycle. Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and ... and sites, providing support during health authority inspections, and offering guidance on quality issues . Ensuring vendors adhere to relevant quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues resulting in the delay of ... maintaining compliance and quality .Must be able to discern the criticality of issues and communicate to management regarding complex issues .Ability to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking a Specialist, QA Process Excellence as part of the Quality team based in Raritan, NJ.Role OverviewThe QA Process Excellence Specialist III role ... is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities within a cell… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …maintaining compliance and quality .Must be able to discern the criticality of issues and to communicate to management regarding complex issues .Ability to ... inspection readiness within facility.Perform internal housekeeping audits.Perform analysis on quality indicating data and identifying trends.Provide oversight… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …automation and controls system software, hardware and associated interfaces inclusive of data management , issues , deviations, corrections, remediation and ... will be responsible in handling day-to-day activities inclusive of life cycle management , issues , deviations, corrections, remediation and improvement efforts of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …this leader.Key Responsibilities Lead and oversee all engineering management including asset/reliability, data systems/automation and ... a change agent to promote flexibility, creativity, and accountability.Advanced project management skills, responsiveness to issues , and demonstrated passion for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be responsible in handling day-to-day activities inclusive of execution, protocol management , vendor management , issues , deviations, corrections 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)
- …support specific and real-time floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample management and data ... according to standard operating procedures and batch records, while recording production data and information in a clear, concise format.Perform tasks on time in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …equipment and capital expenditures (CapEx), ensuring alignment with business objectives, quality , compliance, and cost optimization. The role will work closely with ... cross-functional stakeholders including Manufacturing, Facilities, Maintenance, Engineering, Quality , Finance, Supply Chain and Global Procurement to meet site and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …change controls, document control, process improvement, process validation and data management .Partners with Operational Excellence to implement ... experience ownings SOPs, change controls, investigations, CAPAs and other quality system actions.Ability to engage all levels of the organization,… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …+ You will be responsible for planning and executing audits of vendors' quality management systems, manufacturing processes, and facilities to ensure compliance ... be responsible for regular monitoring and analyzing vendor performance data to identify trends and potential issues ....or medical device manufacturing, packaging and testing processes, and management of Quality Management Systems.… more
- Parexel (Trenton, NJ)
- **Job Title:** Data Management Lead (Medical Affairs) - Oncology **Location:** Fully Remote (US based) Must be able to accommodate West Coast hours. **About ... innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team....+ Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high- quality… more
- Terumo Medical Corporation (Somerset, NJ)
- …The Sr. Clinical Quality Specialist collaborates cross-functionally to resolve complex quality issues , develop quality metrics and dashboards, and ... escalation for clinical suppliers Advising clinical teams on handling noncompliance and quality issues during study execution Collaborating with stakeholders to… more
- MISTRAS Group, Inc. (Princeton Junction, NJ)
- …monitoring, maintenance planning, and specialized engineering, powered by a proprietary management software suite that centralizes integrity data for predictive ... positive work environment that values excellence in safety and quality , free from discrimination and harassment. Every MISTRAS employee...a workplace where all employees are free to raise issues , concerns, and questions for the improvement of our… more
- Neuberger Berman (New York, NY)
- We're seeking a Senior Product Manager to lead the Enterprise Data Management (EDM) User Success & Enablement team-a firmwide function that drives user success, ... Familiarity with Agile frameworks and iterative delivery practices. + Experience with data quality governance, metadata standards, and tools like Collibra;… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …products. Supported by more than 40 manufacturing facilities, we provide high- quality medicines, trusted by healthcare professionals and patients, to more than ... clinical trial outsourcing, vendor selection and contract negotiation, vendor management , and reporting process for Sun Pharmaceuticals clinical development… more
- Port Authority of New York and New Jersey (New York, NY)
- …for mitigating them in the future. + Report on performance monitoring and analyzing data for possible system issues that will require escalation for resolution. ... also experience first-hand the operational cohesiveness between the various departments and management teams that oversee the overall operation. What is unique about… more
- Parexel (Trenton, NJ)
- …the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data . ... quality issue processes by escalating systematic or serious quality issues , data privacy breaches,...(CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management … more
