- Aequor (Houston, TX)
- …through supplier scorecards and performance metrics. Support the development of supply risk management strategies and drive development and implementation of ... is Shashank Kumar and I work at Aequor Technologies. I am working on Operational Buyer Indirect III opportunity in Houston, TX with a great Pharmaceutical company.… more
- Twist BioScience (South San Francisco, CA)
- …and scale. The successful candidate will have a proven track record of audit project management and SOX 404 compliance . You are strong in project management ... in SOX 404 compliance in identifying, assessing and addressing critical SOX compliance risks, operational risks and the relevant compliance processes.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global PV regulations for individual case safety reporting, periodic reporting and risk management . Develops and implements strategic initiatives for global ... address, escalate issues requiring attention or resolution, and proactively drive operational excellence and continuous improvement. Oversees the management of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the responsibility of managing 3 or more direct reports. Responsibilities:Study Management and Leadership:Has primary accountability for operational study-level ... Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study level with responsibility for… more
- Genmab (Plainsboro, NJ)
- …their skills and knowledge on process management & improvement, strategic & risk management planning, change management and stakeholder management . ... the team that is in the leading role in the planning of operational excellence, strategic planning, and innovation implementation for the Global Clinical Drug Supply… 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 ... team collaboration, training and development, employee engagement, and recognition Change Management : Identifying areas for improvement in operational processes… 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...the BPQLs and relevant business partners.Support the R&D Quality Operational Excellence activities, which prioritize and focus on the… more
- Genmab (Plainsboro, NJ)
- …of corresponding actions and processes.Knowledge/SkillsExcellent knowledge of security and risk management frameworks and standards (eg NIST, ISO).Excellent ... having a detailed and thorough understanding of the underlying operational and commercial business processes. The support of our...VP and Global Head of Information Security and IT Risk & Compliance , playing a strategic role… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... ensure timebound progression of portfolio, initiatives for scientific & operational excellence, and other strategic goals that advance functional impactProactively… more
- Merck & Co. (Rahway, NJ)
- …filings.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary.Maintaining an ... and commercialization, proactively identifying risks to influence solutions, driving operational and scientific excellence, actively engaging in two-way communication… more
- Merck & Co. (North Wales, PA)
- …experts who will deliver or facilitate, as needed Ensure accurate forecasts and project risk management Competencies: - - Business Acumen: Ability to engage with ... planning and management experience, including the ability to contribute to operational (short term), tactical (1-2 years), and strategic (3-5 years) planning in… more
- Merck & Co. (Durham, NC)
- …and operational problems through collaboration with peers.-Applies appropriate risk management while adhering to cGMP requirements.Makes decisions guided ... Specialist Quality Technical role is responsible for supporting deviation management , change control, site qualification/validation, equipment qualification, and technical… more
- Merck & Co. (Rahway, NJ)
- …in small molecule process characterization work by learning and utilizing Quality Risk Management (QRM) /Quality by Design (QbD) methodologies and tools ... DescriptionOur Engineers support internal and external manufacturing operations remain operational , continuously improve and innovate. With our extensive range of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within Technical Operations and be responsible for the ongoing site ramp-up, daily operational management , as well as continuous improvement of cGMP Warehouse ... for best practices as per Legend Biotech policies and GXP requirements.Ensure compliance of operational activities with GXP, quality, training, EHS, security… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …-based monitoring (RBM) and Central Monitoring.Responsibilities:CRA Monitoring Oversight Management :Support monitoring oversight strategy to ensure quality and ... for monitoring the following CRA central oversight activities: Determine CROs compliance with monitoring plan for on-site and remote site visits (expectations… more
- Merck & Co. (North Wales, PA)
- …organizational excellence practices such as technical standards, process platforms, operational procedures, data management and visualization, and laboratory ... filtration (ATF), centrifugation, and depth filtration. Coordinate staffing, inventory, waste management , equipment upkeep, budget management , data analysis, and… more
- Merck & Co. (Rahway, NJ)
- …and global functions such as infrastructure, engineering, system security, risk management , etc.Education Requirement:-Bachelor's degree in automation, ... analyzing and solving incidents, problems, identifying root causes and performing crisis management roles.Lead efforts to map and design operational service… more
- Merck & Co. (Rahway, NJ)
- …works closely with security operations teams, information technology teams, enterprise risk management teams, executive decision-makers, industry peers, and ... partners in order to propose ideas and innovative solutions that reduce risk and enable new organizational capabilities.The CTI Senior Specialist is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical Affairs, Translational ... Research, Research, Informatics Services, Project Management and Operational Management . The...architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business… more
- Merck & Co. (Lower Gwynedd, PA)
- …are maintained in a validated state, as part of an active/ongoing lifecycle management program and in compliance with current GXP requirementsUse technical ... coaching.Work closely with divisional/enterprise IT teams, global infrastructure, and risk /security organizations to ensure that project deliverables and ongoing… more
