- Cepheid (Miami, FL)
- …assessment to identify and implement improvements. This position will work with the Senior Manager Quality Systems Compliance .This position is part of ... waiting.Learn about the Danaher Business System which makes everything possible.The Senior Quality Systems Specialist is responsible for functioning as Lead… more
- Eisai, Inc (Exton, PA)
- …and approves documentation of SOPS, SDLC tasks, and other GxP Systems Quality Assurance processes for use in supporting compliance with GxP regulations and ... while maintaining the intended level of controls. The Senior Manager is responsible for supporting quality awareness...of controlled documents related to GxP Systems Quality Assurance.Internal and External Auditing and Compliance … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team will consist of managing external resources and some internal resources.Ensure safety, quality , and compliance is the main goal for all new and ... Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position… more
- Merck & Co. (Durham, NC)
- …during tours to provide area/process overview information to visitors/auditors upon request - - Quality & Safety Compliance - Foster strong safety culture on the ... safety issues and completing corrective/preventative actions - Drive culture of compliance through actions, consistent quality -driven decision making, and… more
- Merck & Co. (Durham, NC)
- …product(s).- As a result, VCM Product Managers have direct impact on cost, quality , customer service, and compliance which ultimately affects access, continuity ... the following: Product/ Process Development, Manufacturing Operations, Finance, Regulatory, Quality , Compliance , Supply Chain and Commercial OperationsUnderstanding… more
- Merck & Co. (Rahway, NJ)
- …the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... a lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines,- strategies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …RIM)Work with GRA stakeholders to define appropriate KPIs/metrics to track process compliance , performance and adherenceWork with the data/ systems SMEs to define ... areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and implement process improvements related to investigations cycle time, closures, quality , and compliance .Develop strategies to increase investigations output ... Legend Biotech is seeking an Investigations Manager as part of the Technical Operations team...while maintaining investigations quality . As needed, review investigations to ensure consistent … more
- Genmab (NJ)
- …of data standards to support the portfolio towards the ultimate objective of data quality and consistency across programs and systems . This role reports to the ... (SDTM) standards that support the scientific need of a study/program while ensuring quality , consistency and compliance to CDISC standards and other industry… more
- Merck & Co. (Rahway, NJ)
- …Management Section of the GCS Planning organization.- Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic ... Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.-Responsible and accountable… more
- Novo Nordisk Inc. (Durham, NC)
- …on shop floor & improvement of Quality processes. Relationships Reports to Manager , QA. Essential Functions Ensure plant systems batch release & relevant ... preferably in the pharmaceutical industry Demonstrated expertise in Regulations & quality systems (eg, commercial product disposition, DV/CAPA, Change Control,… more
- Merck & Co. (Rahway, NJ)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... supplies.-Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related… more
- Merck & Co. (Rahway, NJ)
- …more productive and enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position will report to ... simulation, and analysis of complex biological, pharmacokinetic, and pharmacodynamic systems .Primary Responsibilities: Problem discovery and strategy In close partnership… more
- Aequor (Aliquippa, PA)
- … systems planning, procurement, master data, pricing and contracting, quality , manufacturing network, supply chain, technical operations, and information ... systems . Facilitate resolution of quality issues within...objectives: Ensure current Good Manufacturing Practices (cGMP) and Safety compliance . Utilizes project management skills to support Logistic Service… more
- Merck & Co. (Durham, NC)
- …approved by Quality managementConsults on an as-needed basis with next-level manager on more complex release decisions and/or issues that impact other units with ... Assurance (QA), Quality Auditing, Quality Management Standards, Quality Standards, Regulatory Compliance {+ 5 more}-Preferred Skills:Job Posting End… more
- Raytheon (Tucson, AZ)
- …team management and closely works with the program chief engineer and program manager , supply chain, suppliers, operations, quality and working across the ... services, materials, processes, analysis, test and documentation.The Precision Control Actuation Systems (PCAS) department is part of Mechanical Engineering, and we… more
- Beckman Coulter Diagnostics (Miami, FL)
- …areas of medical devices, engineering, or quality assurance.Strong knowledge of Quality , Regulatory compliance , and operations systems and processes, ... Board (CRB). This position is part of the Global Quality System and Compliance Group located in... certification is preferred.Demonstrates knowledge of domestic and international quality systems and other standards such as… more
- Merck & Co. (Durham, NC)
- …training to mechanics and other maintenance personnel.Interface with safety, production, and quality groups to ensure facility operations and systems comply with ... and implementation of preventative and predictive maintenance programs to assure compliance with quality , regulatory, and reliability requirements and… more
- Merck & Co. (Durham, NC)
- …the Associate Director of Maintenance and Engineering or the shift Maintenance Manager , the Maintenance Specialist primary responsibility will be to help facilitate ... and embraces an inclusive team culture, including interaction with Operations, Quality , Automation, Technology, and other groups as required. The candidate will… more
- Merck & Co. (Durham, NC)
- … compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control).- ... and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director).-This role… more
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