- Insmed Incorporated (NJ)
- …We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will ... requirements while maintaining operational excellence. The Executive Director, Cybersecurity & Risk Management plays a critical leadership role in safeguarding that… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigation Lead is an exempt level position reporting to the...and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.Perform analysis on quality indicating data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change controls, draft ... the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based in Remotely. Role… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and… more
- Merck & Co. (Rahway, NJ)
- …that accelerate our scientists' ability to discover and develop innovative medicines that change the course of human health. In the RaDS value team, the Product ... Manager to join the RaDS Product organization. The position will report to the Lead of the Disease Biology and PharmTox Product Line. The ideal candidate will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Inc. (NNI). At Novo Nordisk, your skills, dedication and ambition will help us change lives for the better. In exchange, we'll offer you an opportunity to work ... Real Estate; Digital, Data and IT; Finance and Tax) and complex and high- risk supplier contracting. Relationships This job reports to the Managing Assistant General… more
- Repligen (Waltham, MA)
- …are seeking an experienced IT Manager, SOX & ITGC Compliance to lead the design, implementation, and ongoing effectiveness of internal controls over financial ... digital systems. This role drives the ITGC audit program, advises on risk mitigation strategies, and partners closely with Internal Audit, IT, Financial Reporting,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …environment.Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and ... and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management...for MES and/or digital projects and ensures that quality, risk , cost, time are managed within the overall approved… more
- Merck & Co. (Rahway, NJ)
- …strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics and Distribution ... analysis of inputs, outcomes, risks, and company-wide prioritization. Essential Responsibilities: Lead , mentor, and develop a team of technical staff, fostering a… more
- Merck & Co. (Rahway, NJ)
- …Automation Solutions, Biopharmaceutical Industry, Capital Project Management, Capital Projects, Change Management, Cybersecurity Risk Management, Data Analysis, ... data integrity, cybersecurity, and lifecycle best practices (commissioning, qualification, change control, obsolescence, periodic reviews)Provide end-to-end operations support for… more
- Repligen (Waltham, MA)
- …seeking a hands-on, strategic Director of IT & OT Infrastructure to lead the design, implementation, and ongoing optimization of our global technology ... MSPs, and vendors to ensure high-quality, secure, and reliable services.You will lead and develop a high-performing team, drive continuous improvement, and ensure… more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... on the analysis of inputs, outcomes, risks, and company-wide prioritization.Essential Responsibilities: Lead , mentor, and develop a team of technical staff, fostering… more
- Twist BioScience (South San Francisco, CA)
- …and ISO 14971. This position is also responsible for conducting risk assessments, developing, and implementing corrective actions, and providing technical support ... and maintain a QMS that complies with ISO 13485 and ISO 14971.Conduct risk assessments to identify and assess potential hazards associated with genomic products and… more
- Syner-G BioPharma Group (Boston, MA)
- …or systems for compliance with manufacturing requirements and facility fit. Lead start-up activities, including commissioning and qualification of facilities, ... utilities, and equipment (FUE).Assist with risk assessments, feasibility reviews, risk mitigations, and testing of process materials to ensure compliance with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to standardize, optimize, and innovate signal ... best practices, foster a culture of continuous improvement in benefit- risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, execution and ... of successful Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality representatives, and act… more
- Merck & Co. (Boston, MA)
- …development, strategy execution and value realization, enterprise strategic planning, risk management, and strategic venture investments in healthcare as part ... rigorous assessments that can inform leadership decision-making; develop, refine and lead Oncology strategic initiatives across our Company; and help evolve and… more
- Insmed Incorporated (NJ)
- …Establish QA-QA relationships and checkpoints for critical CDMOs and service providers. Lead or support Quality Agreements, risk assessments, audits, and ... and vendor management experience.Proven expertise in root cause analysis, investigations, change control, and Quality risk management.Direct experience with… more
- Novo Nordisk Inc. (Boulder, CO)
- …will manage CMO's to ensure the continuous supply of product and apply risk mitigation strategies, as well as perform formulation studies in a laboratory setting ... as needed. This position will lead a team of Drug Product Managers and manage...and troubleshoot equipment and systems required Ability to perform risk assessments required Experience in problem solving and continuous… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Director of Account Management to align initiatives with strategic goals Lead planning sessions and provide updates on operational execution and alignment ... visualization tools to present clear and actionable insights to stakeholders Conduct risk assessments for all initiated programs to identify potential obstacles and… more
