- Aequor (Thousand Oaks, CA)
- …of 's document repository software. Support the development of and approve risk assessment summary reports. Competencies: Ability to interpret and evaluate ... global sites and disciplines. Ability to deal with ambiguity. Familiarity with Risk Assessment tools and methods. Demonstrated ability to work independently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communicated and that audit targets for MA audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within ... stakeholders to streamline the product lifecycle process and develop risk mitigation strategies.Provide comprehensive quality oversight and strategic quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and strategy for the group including overall vision for a robust risk assessment , mitigation, central (statistical) monitoring and signal detection. Identifies ... immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy...across different disease areas, and the ability to determine risk factors with and for other technical departments (eg,… more
- Merck & Co. (Boston, MA)
- …scientific data and technology products. Perform other product related duties (eg, risk assessment and vendor engagement) as needed. Collaborate closely with ... user experience researchers, engineers, and data scientists to assess value risk , usability risk , feasibility risk and business viability risk .Conduct… more
- Formation Bio (New York, NY)
- …those powered by large language models (LLMs) for classification, recommendation, and risk assessment .In this role, you'll apply cutting-edge machine learning ... and deployment of machine learning models for classification, recommendation, and risk assessment to enhance decision-making in drug development. Build… more
- Merck & Co. (Durham, NC)
- …Manufacturing Process Validation, People Leadership, Process Optimization, Quality Risk Assessment , Regulatory Inspections, Regulatory Requirements, Scope ... Resource activities including one-on-one meetings, team development, hiring, talent assessment , and performance reviews. Responsible for the facility requalification… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the study is executed according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and ... DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place...Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log) and other… more
- Merck & Co. (Rahway, NJ)
- …our products. The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and ... talent Development.-The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including… more
- Aequor (Aliquippa, PA)
- …and approval, including but not limited to deviations, CAPAs, change controls, risk assessment , and validation records Perform incoming raw material inspection, ... standardized mechanisms to measure progress against targets Understand and incorporate risk management strategy into overall supply chain strategy Ensure compliance… more
- Merck & Co. (Rahway, NJ)
- …and documentation of all stages of cell culture process commercialization. Risk assessment , control strategies, process comparability reports, Process ... and inspire accountabilityEthical, resilient, and committed to excellenceSkilled in risk management, team facilitation, and strategic planningExperience in commercial… more
- Repligen (Waltham, MA)
- …regulatory requirements (preferred but not required). Excellent contract drafting, negotiation, and risk assessment skills. Ability to work in a fast-paced ... and consulting agreements.Ensure all contracts align with company policies, risk management strategies, and regulatory requirements.Work closely with procurement,… more
- Merck & Co. (Rahway, NJ)
- …of the following: process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, ... and/or regulatory submissions (BLA/MAA/JNDA etc.).Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.Experience and aptitude to lead, work, and collaborate in internal and external… more
- Merck & Co. (Rahway, NJ)
- …analysis, and documentation of all stages of cell culture process commercialization. Risk assessment , control strategies, process comparability reports, Process ... performance qualification, and/or regulatory submissions.Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA).-Proven leadership and project management skills to drive… more
- Merck & Co. (Rahway, NJ)
- …Line Engineering, Clinical Judgment, Communication, Flux Analysis, Human Health Risk Assessment , Innovative Thinking, Interpersonal Relationships, Mammalian Cell ... Culture, Manufacturing Processes, Mentorship, Metabolomics, Molecular Biology, Omics Technologies, Process Characterization, Project Leadership, Project Management, Proteomics, Scientific Leadership {+ 3 more}-Preferred Skills:Job Posting End Date:07/4/2025 *A… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, ... and this position acts as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type C, Scientific Advice) with… more
- Aequor (Devers, TX)
- …with Contractor Safety, Safe Work Permit Program Support EHS training and Risk /Hazard Assessment Initiative/autonomy EHS audits / Field Audits and Inspections ... and teams; and EHS self-assessments, inspections, GEMBAs, and audits. Perform risk and hazard assessments throughout the campus. This includes involvement in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for presenting the strategy in health authority inspections.Assess change controls, risk assessment , trend reports and SOPs/Work Instructions for contamination ... impact.Support significant Environmental Monitoring and Sterility related investigationsSupport Facility expansion activities including having a robust contamination approach and integration with the existing facility.Support training of new and existing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for leading company response from Deal to Contract (includes pre-deal assessment /analysis, development of business cases for Pricing Committee, offer development, ... Functions Pre-Deal o Contributes to continuous improvement and accuracy of the Contract Assessment Model (CAM) to drive and inform data driven decisions from Pricing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in support of company objectives, operating model decision, mitigate decision risk , drive action plan development and ultimately improve commercial and clinical ... recommended actions and potential counter measures as appropriate; Ensures rigorous assessment of the accuracy, validity and reliability of gathered information… 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 and ... fast-paced environment, continuous improvement, project management, change management, and risk management.Responsibilities:Leadership, Direction, and Strategy: Is accountable for the… more
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