- Repligen (Waltham, MA)
- …3 highly motivated and collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance . The team plays ... MA, and will report to the Senior Manager of Supplier Quality .Responsibilities Supplier Performance Monitoring and ReportingCollect, analyze, and report on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cGMP manufacturing experience preferred.Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processesAbility to ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr . Investigator Compliance Specialist as part of the Technical Operations team based… more
- Merck & Co. (Durham, NC)
- …(LMS&T) is seeking a highly motivated individual for the role of Sr . Specialist, Engineering.- This role will provide end-to-end support of manufacturing science ... vaccine products including Drug Substance, Drug Product, and Analytics.-We are seeking a Sr . Specialist to join our Live Virus Vaccine (LVV) team. The successful… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ... ensure ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including status and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project plans across functional teamsDefines the interdependent deliverables and ensures that quality , risk , cost, time are managed within the overall approved ... in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager, PMO as part of the Technical...application to drug development required to deliver time, cost, quality , and risk management to teams.Demonstrated results… more
- Merck & Co. (Rahway, NJ)
- …method transfers and/or validations across vaccine and biologics programs including quality risk assessments/gap analysis.Provide sponsorship of both in-line and ... Job Description Global Quality Large Molecule Analytical Sciences (GQ- LMAS) -...and teamwork skillsSelf-motivated with a positive attitude and proven performance recordKnowledge with drug substance and drug product release,… more
- Repligen (Waltham, MA)
- …drugs.This role will be based in Waltham, MA and will report to the Sr . Director, Quality - Quality Network Leader, Chromatography & ... inputs for monthly KPI's and management review meetings with the Senior Management team.Facilitate operational excellence initiatives in Quality … more
- Merck & Co. (Rahway, NJ)
- …quality by design` principles in assigned clinical trials.The CQOM will develop Risk Assessment and Categorization Tools and Quality Plans in partnership with ... therapy area will collectively and periodically (eg quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify any… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …but not limited to Operations, MSAT, Facilities, C&Q, Project Management, and Quality .Work closely with Sr . Manager, Strategic Initiatives to support various ... EMPQ, APS, PPQ, preferred.Experience with change management/change control and quality systems.Experience with FMEA and risk assessment tools.Experience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …building a high-performing global sourcing organizationAssess and periodically update risk scores for BOM and other high- risk materials.Co-develop ... sheet development, and negotiate contracts.Lead cross-functional teams and collaborate with Quality , Legal, CMC, MSAT, Manufacturing, Supply Chain, and Regulatory to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …metrics; these metrics will range from employee engagement, safe behavior, quality performance (right first time), schedule adherence, and productivity ... Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management of staff in a growing operation in terms of volume/output… more
- Merck & Co. (Rahway, NJ)
- …and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.Work collaboratively ... and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality , and Supply Chain from early development through to commercial… more
- Formation Bio (New York, NY)
- …Monitor vendor performance and enforce contractual obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and Data ... requirements. Identify opportunities for cost savings, contract optimizations, and risk mitigation. Implement procurement analytics and reporting tools to provide… more
- Merck & Co. (Rahway, NJ)
- …administrative processes.Support the development of GMP Documentation such as:- Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and ... manage and engage personnel, plan and assign work, and manage performance .- Provide guidance, coaching and mentorship, motivating staff to achieve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team, developing standard approaches that foster a reputation for outstanding quality , collaboration, rigor, and follow-through. Collaborate with the Head Global RD ... the growth and development of team members to enhance overall performance and engagement. Operational Strategy Implementation: Cascade and disseminate operational… more
- LifePoint Health (Beckley, WV)
- …and evaluates the activities, functions, and management of personnel within the Quality / Performance Improvement, Risk Management, and Medical Staff Office ... they can raise concerns or report suspected code violations. ESSENTIAL FUNCTIONS Quality Facility oversight of performance improvement program Facility oversight… more
- Capital One (Richmond, VA)
- Sr . Risk Associate - Risk Management Risk (RMR) ** Risk Management Risk (RMR) is seeking a Senior Associate to join our Risk Office team. ... Associate will have the opportunity to apply their risk management, quality assurance and process management/...Training Processes. This role is focused on supporting our Senior Process Risk Office Lead and various… more
- Capital One (Mclean, VA)
- Sr . Risk Manager, Data Risk ... risk mitigation efforts, and influence decision-making at senior levels. + Metadata, Data Quality , and Governance: ... and creative. As a Second Line Validator - Data Risk Management ( Sr . Risk Manager)...and functions on initiatives related to metadata management, data quality , data governance, and data stewardship to ensure risks… more
- Capital One (Mclean, VA)
- Sr . Risk Manager - Data ... risk mitigation efforts, and influence decision-making at senior levels. + **Metadata, Data Quality , and ... a Second Line Risk Advisor - Data Risk Management ( Sr . Risk Manager)...and functions on initiatives related to metadata management, data quality , data governance, and data stewardship to ensure risks… more
- Santander US (Odessa, FL)
- Sr . Analyst, Business Control & Risk ...and use of control frameworks. * Control testing or Quality Monitoring experience. * Operational Risk Management ... to Talk to You!** **The Difference You Make:** The Sr . Analyst, Business Control & Risk Management...will become a subject matter expert and assist with quality testing activities, as assigned, such as transactional testing… more
