- Legend Biotech USA, Inc. (Raritan, NJ)
- …reports, interpret results, and generate technical conclusions consistent with quality risk management principles.Recognize patterns and trends in reported data ... sample materials.Perform spot-checks in the QC Laboratories to ensure compliance with written regulations, policies, procedures, and global procedures.Strive...and communicate to management .Require minimal direction to complete tasks, knows how to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to ensure processes are robust and continuously improving. Work with the Data Management and Integration Lead and Process Validation lead on the establishment and ... management of a process monitoring program. Establish metrics for...manufacturing operations.Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processesAbility to work… more
- Merck & Co. (Rahway, NJ)
- …areas of the enterprise. Areas included, but not limited to are, overall supplier management , compliance , risk management , diversity spend, and ... directed.-In addition to providing primary expertise in Capital planning, engagement management and performance improvement the senior specialist will provide direct… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards ... in fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and… more
- Genmab (Plainsboro, NJ)
- …policies; and (ii) the implementation and oversight of Genmab's third-party privacy risk compliance function. Successful candidates will have a deep ... the implementation of technical rules and standards for privacy compliance in data life cycles and deployment of technologies...oversight of Genmab data processors in accordance with Genmab's risk management framework and data privacy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …globally and with external parties as required.Champions 'Quality by Design' and Quality Risk Management approaches to quality management within Daiichi ... other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and...sites.Introduce and implement methods to detect fraud or site non- compliance such as: different approaches to data review in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads (RQLs), ... the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from...and external stakeholders of R&D Quality.Support the oversight and management of CAPAs by tracking and following up on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all ... ensure compliance with Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log) and other risk … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relations, internal communications, public disclosures, social media policies, compliance , crisis communications, and diversity initiatives. Develops contract ... within DSI and global entities, advising on legislative and regulatory compliance , lobbying activities, political contributions, public policy development, and state… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to identify QA risks at CMO's and support the recommended courses of risk treatment and resolution manner in appropriate way and to ensure continuous improvement ... in the management of CMO risks. Interacts with DS affiliates to...approval of documents associated with validation or qualification activities, risk assessment strategies, technical studies and applicable changes that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …best practices of data security, role & security model design, hierarchical security, compliance and CAPA response & management ; knowledge of industry standard ... Administration is a member of the Biostatistics and Data Management Data Operations team and serves both as a...of identified access discrepancies per study to maintain overall compliance and inspection readiness of the application. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally ... role of both operational strategy and study execution. Responsibilities:Study Management & Leadership:Has primary accountability for operational study level time,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Company and/or departmental expectations and goals as identified by senior management .ResponsibilitiesActs as a brand attorney and lead legal advisor for the ... both independently and for review, approval, and use by Legal Affairs management . Independently negotiates contracts and other issues with third parties (vendors,… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
- Merck & Co. (Rahway, NJ)
- …country program rollout with cross divisional and market stakeholdersStrategic thinking, risk management , and roadmap planning for data product evolutionEnsure ... premier "Data First" commercial biopharma organization.In this Associate Director Data Product Management role, you will be part of the HHDDA Commercial Data… more
- Formation Bio (New York, NY)
- …health authority audits.Responsibilities Develop, implement, and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory ... and implement corrective and preventive actions (CAPAs) effectively. Proficiency in quality management tools and methodologies (eg, risk assessment, root cause… more
- Merck & Co. (Rahway, NJ)
- …devices and combination products globally.- Experience in design controls, device risk management , medical device, complex combination product kits, prefilled ... and local site procedures for safety, quality, and regulatory compliance - Understand the big picture, and how activities link...to our Company strategy and business goals- Utilize device risk management tools to build device or… more
- Tris Pharma (Monmouth Junction, NJ)
- …Leadership team including insights on financial performance, capital allocation, and risk management ; Directs cost monitoring and reporting activities; Drives ... In depth knowledge of corporate financial law, compliant financial reporting and risk management practices Excellent knowledge of data analysis and forecasting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …completed in compliance and meets Novo Nordisk's business standards Risk Management : Assessing and mitigating risks associated with operations, implementing ... to make a difference? The Position Drive portfolio strategy and study management activities and manage cross-functional study team, external service providers (CROs,… more
- Merck & Co. (Rahway, NJ)
- …with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, ... in layman's terms to facilitate cross-functional understanding.Development experience in risk -oriented, regulated environmentsDevelopment project leadership with a proven track… more
