- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin our team as a Clinical Quality Operations Lead - Inspection Strategy and be at the forefront of developing and implementing policies, ... developed to lead /support regulatory GCP inspections.In this role you will: Lead Regulatory Compliance:-Develop and maintain GCP inspection procedures and… more
- CIRCOR International, Inc (Tampa, FL)
- Quality Inspection Lead & Level I Admin ORGANIZATIONAL STRUCTUREBUSINESS: Leslie Controls, IncLOCATION: Tampa, FLDIRECT REPORTING: Quality ... and accuracy. Also assist in other areas and functions associated with quality inspection to include NDT, GD&T, document review, and training of quality… more
- ConsultNet (Columbus, OH)
- …and promotion of the interests of firm. Duties and Responsibilities: Able to lead full General Contractor project with autonomy & initiative. Takes ownership of a ... Capable of building, updating, enforcing a complete schedule from start to finish. Can lead a card trick effort. Maintains set schedule and adjust the schedule to… more
- ConsultNet (Columbus, OH)
- …technical management for all construction project operations. The Senior Superintendent is the lead for job site safety, quality control, and project schedule ... when project timing permits. Understands and manages permitting and inspection process/sequence/requirements. Completes superintendent administrative requirements (Daily reports, 2-week… more
- CIRCOR International, Inc (Warren, MA)
- …of both centrifugal and positive displacement technologiesPosition SummaryWe are seeking a qualified Quality Inspection Supervisor to lead and manage the ... our unionized inspection team in a manufacturing environment. As the Quality Supervisor, you will play a crucial role in ensuring production efficiencies,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QA Investigations Lead as part of the Quality team based in Raritan, NJ. Role ... Overview The QA Investigations Lead has the responsibilities for providing quality oversight over the production of a personalized cell therapy to support both… more
- Merck & Co. (Rahway, NJ)
- …company's Research Laboratories Quality Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within ... Quality Risk Management.As required, participate in Regulatory Agency inspection activities.Deliver stewardship for company's corporate initiatives from a … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the ... Plan together with the supported GPTs including the quality risk assessments and inspection readiness components...and respective CROs in order to ensure high data quality and proactive detection and resolution of issues. Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan ... study budget is reconciled with Finance on an ongoing basis.Support all inspection readiness and quality initiatives pertaining to assigned stud(ies).Ensures… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan ... study budget is reconciled with Finance on an ongoing basis.Support all inspection readiness and quality initiatives pertaining to assigned stud(ies).Ensures… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …during regulatory inspection through close collaboration with Operations and Quality teams Lead cross-functional investigation teams to identify root cause, ... collecting necessary data and information associated with operational deviations. Will lead and facilitate root cause analysis investigations with site personnel and… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, our policies and procedures, quality -standards and adverse event reporting requirements internally and externally.Acts as ... audits/inspections-and overall site performance.Identifies, assesses and resolves site performance, quality or compliance problems and-escalates per defined CRA Escalation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical ... data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol defined analysis endpoints (primary, secondary, exploratory, etc.).… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stakeholders to optimize Statistics technology, processes, and standards (improving quality / inspection readiness, decreasing cycle times, and reducing costs). ... manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Supervise a team of QA Investigations Leads. Provide guidance to the Quality Leaders about handling the various nonconformances. Lead the daily ... QA Investigations Supervisor (2nd shift) as part of the Quality team based in Raritan, NJ. Role Overview The...touch point meetings with the team and monitor workload. Lead the daily triage meeting for nonconformance initiation. Support… more
- Merck & Co. (Durham, NC)
- …drug product, including biotech culture growth, harvest, lyophilization, product inspection , utilities, and warehouse.-As the team finishes design and construction ... unique opportunity to give input in the design process, startup their areas, and lead the teams to full production.Our ability to excel depends on the integrity,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical ... data collections ensuring all clinical & companion diagnostics data meet quality requirements and protocol defined analysis endpoints (primary, secondary, etc.)… more
- Aequor (New Brunswick, NJ)
- …for the stability program on assigned brand (s) and acts as Stability Product Lead . Participates on transfer team for new products to internal and external sites (as ... Market Action Fact Finding, and other investigations related to potential quality issues and/or deviations from standards. Leads work activities involving Change… more
- Novo Nordisk Inc. (Durham, NC)
- …Join Team Novo Nordisk and help us make what matters. The Position Lead the technical analysis, process development/improvements & quality topics. Work with ... our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to optimize Data Management technology, processes, and standards (improving quality / inspection readiness, decreasing cycle times, and reducing costs).Leads ... assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables on time and within budget to support drug development… more
