- Merck & Co. (North Wales, PA)
- …executing CMC development plans.--Under the guidance of the CIPM Staff Manager & Portfolio Lead , the core responsibility of this senior Project Manager (PM) role ... Project Management, Project Planning, Project Scheduling, Project Strategy, Regulatory Compliance, Results-Oriented, Risk Management, Software … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in Raritan, NJ. Role OverviewThis position will be responsible for providing project lead support for strategic initiatives and capacity expansion activities ... decision criteria for the project .Develops options and solutions to complex project risk problems, providing guidance to leadership including trade-off and… more
- Merck & Co. (Rahway, NJ)
- …device product development, such as manufacturing process development and validation, design control , risk management, material and molding, design validation to ... their interdependencies with design verification, including but not limited to, design controls , risk management, materials & molding, process development and… more
- Merck & Co. (Rahway, NJ)
- …Expertise: Utilize extensive experience in design controls , device transfer, control strategies device risk management, and design verification testing to ... prefilled syringes, and complex drug delivery systems.Proven expertise in design controls , risk analysis, control strategies, design verification… more
- Merck & Co. (Rahway, NJ)
- …equipment, as well as qualification and validation, medical device design controls and device risk management, and design verification/ validation.Demonstrated ... and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible for technical leadership of key… more
- Merck & Co. (Rahway, NJ)
- …Services primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ResponsibilityUnder ... both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will...our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management… more
- Merck & Co. (Rahway, NJ)
- …Responsibilities:Utilize extensive experience in design controls , device transfer, control strategies, device risk management, and design verification ... expert on the device components and combination products and lead a cross functional team members to support global...in managing external partners and suppliers.Proven expertise in design controls , risk analysis, control strategies,… 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
- Merck & Co. (Rahway, NJ)
- …equipment, as well as qualification and validation, medical device design controls and device risk management, and design verification/ validation.Demonstrated ... cross-modality technical team. As an individual contributor, the associate director will lead cross functional teams.- The leader will be responsible for executing… more
- Merck & Co. (Rahway, NJ)
- …of the following: process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, ... validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external… more
- Merck & Co. (North Wales, PA)
- …processes including packaging equipment design & development, ensuring packaging process control and efficiency and providing on-going packaging and device technical ... strategic acumen, and execution, along with leadership skills to lead complex cross functional projects.Essential Duties and Responsibilities:The engineer will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …not limited to IQ/OQ/PQ, EMPQ, APS, PPQ, preferred.Experience with change management/change control and quality systems.Experience with FMEA and risk assessment ... stakeholders including but not limited to Operations, MSAT, Facilities, C&Q, Project Management, and Quality.Work closely with Sr. Manager, Strategic Initiatives to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CAPA Management Process for the respective business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality execution across Medical ... monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process… 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 ... party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make informed… more
- Genscript USA Inc. (Piscataway, NJ)
- …and project teams. Support permit applications and regulatory reporting. Lead site inspections, audits, and emergency drills. Serve as a liaison with ... federal regulations. The ideal candidate will have strong experience in construction project support, including providing EHS input during early design and planning… more
- Merck & Co. (Rahway, NJ)
- …GMP Auditing, Interpersonal Relationships, Manufacturing Processes, Manufacturing Quality Control , Process Improvements, Quality Assurance Systems, Quality Risk ... are not restricted to:Advise supported areas on requirements for all assigned project responsibilities as related to quality and our company's standards and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... and productivity improvements.Support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing and project planning experience preferred.Provide technical expertise of Change Control process as well as oversight of the MES team to ensure ... be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the… more
- Monster (Northfield, IL)
- …medical device industry. Experience with medical device requirements (Class I-II), design controls , and assessment of risk . Experience designing and launching ... Provide expertise on product design and optimize design specifications. Lead product design assignments in product development initiativesJob Description… more
- Capital One (Richmond, VA)
- …environment changes, industry trends, and understand their impacts to our efforts + Lead risk assessment project delivery, including providing oversight of ... and other governance functions + Drive development of associated risk controls , issues and/or mitigation plans to...contribute to continuous improvement of risk and project / program management practices + Lead … more
