- Merck & Co. (North Wales, PA)
- Job Description- Role Summary:The Process and Systems Lead Senior Director, Medical Operations ( Lead , P&S) is a leadership role within Global Medical and Value ... (GMSA) that reports directly to the Executive Director (ED) Global Medical Operations Lead .-The Lead , P&S is responsible for managing people and building optimal… more
- Merck & Co. (Rahway, NJ)
- …quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality ... quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The position will… more
- Merck & Co. (Durham, NC)
- …our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn our right to produce. ... local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products.This role is within a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Oncology and Specialty Medicine portfolios, in alignment with the business strategy. Lead the PV inspection management activities by ensuring readiness, ... Plan together with the supported CSPV teams, including the quality risk assessments and inspection readiness components...lead as the Head of PV QA with Quality Reviews of respective product profile to ensure appropriate… more
- Merck & Co. (North Wales, PA)
- …to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & ... and other worldwide regulations and our Compa requirements.This position provides Device quality engineering and quality assurance support and leadership to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Quality team based in Raritan, NJ. Role Overview The QA Investigations Lead has the responsibilities for providing quality oversight over the production of ... multiple myeloma. Legend Biotech is seeking a QA Investigations Lead (2nd or 3rd shift) as part of the...investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and… 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. (Plainsboro, NJ)
- …audits/inspections on all case processing and compliance reporting processes and take lead role in the audit/ inspection process (eg, prepare pre-audit requests, ... 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… more
- Novo Nordisk Inc. (Durham, NC)
- …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 ... & service contracts. Relationships Manager or Senior Manager. Essential Functions Lead reliability program with implementation of projects focused on improving… 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. (Durham, NC)
- …embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.The Lab Senior ... Responsible for supporting our Manufacturing Division,- Divisional site mission by assuring quality of products and services are of the highest quality ,… 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external stakeholders to optimize technology, processes, and standards (improving quality / inspection readiness, decreasing cycle times, and reducing costs)- ... (from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time and within budget. The position holder… 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
- 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... work package owner on IT Infrastructure related projects and lead internal and external team working as part of...Service delivery and Incident response) IT Infrastructure SME for Quality assurance / GMP and Validation: Maintain qualified state… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and equipment commissioning and validation. Key Responsibilities Develop strategy and lead the implementation of systems and processes that will enhance the ... Monitoring Controls, Optima Line and Ignition software implementation, AVI (Seidenader Inspection ), WLS Labeler, and Dividella Cartoner. Develop and maintain strong… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure that shared point data is current and accurate- In collaboration with the Lead Global QA Strategy and Operations (RDPVMA QA), Collate and produce accurate and ... assigned to individuals are current and up to date- Support regulatory inspection related activities as required such as organizing CAPA coordination teams, ensuring… more
