- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Responsible to complete on paper basis audit and to monitor vendor performance management program . Support the issue and communication of audit plans, agenda ... documents that set strategy in QA GMP Audit processes for contribution of Quality Management System (QMS) establishment processes in collaboration with GMP … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Scientist, Device Risk Management Lead , is a crucial member of our team, responsible for spearheading risk management efforts in ... years of experience in pharmaceutical development, device development, device systems operations, quality management , or a related area. Strong knowledge of… more
- Merck & Co. (Rahway, NJ)
- …Devices Design, Negotiation, Process Manufacturing, Product Design, Production Process Development, Project Management , Quality Management Systems (QMS) {+ 4 ... to set tactical and strategic direction on programs they lead to ensure high quality products and...development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and… more
- Formation Bio (New York, NY)
- …driving near-term development milestones until steady-state ownership is established.Key ResponsibilitiesDiligence Program Management Lead and manage the ... faster and more efficiently.About the PositionFormation Bio is seeking an Associate Director, Program Management - Asset Diligence & Integration to partner with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …(APS benchmarking, Validation Lifecyle Responsibilities, OOS monitoring and trending program )Contribute to developing and/or improvements to quality systems ... multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based...process validation activities in support of the commercial Carvykti program both within Legend but also externally with our… more
- Bayer (Whippany, NJ)
- …organization and establishes a strategic roadmap, defining critical topic areas and program offerings to address both immediate and long-term capability gaps. TB4L ... real-time mentorship for team members at all levels. Training Program Administration: Oversees spending for classroom-style training initiatives, ensuring adherence… more
- Formation Bio (New York, NY)
- …the strategic development and operational management of Formation Bio's quality assurance program to support the growing drug development capabilities. ... and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the...requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of… more
- Formation Bio (New York, NY)
- …and clinical studies. Collaborate with cross-functional teams (Clinical Development, Regulatory, Program Management , etc.) to shape and refine Clinical ... faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic direction for the clinical… more
- Merck & Co. (Rahway, NJ)
- …Governance Management , Leadership, Oncology, Operational Excellence, Privacy Compliance, Quality Management , Risk Management and Mitigation, Risk ... D, Medical Sciences;MBA or innovation/entrepreneurial certification preferredRequired Skills: Academic Quality Improvement Program (AQIP), Biopharmaceutical Industry, Biopharmaceutics,… more
- Merck & Co. (Rahway, NJ)
- … and ensure raw materials are ordered and available for manufacturing activities Lead data management activities related to communication through FLEx Scheduling ... (3) years' experience in a functional area, such as Operations, Management , Quality , Technical Operations, Technology, Engineering Preferred Experience and… more
- Merck & Co. (Rahway, NJ)
- …group of stakeholdersAbility to manage competing priorities with effective collaboration and program management skillsHigh degree of ethics and ability to build ... Patient Advocacy, Patient Engagement, Professional Networking, Project Facilitation, Project Management , Quality Systems Compliance, Regulatory Affairs Compliance,… more
- Merck & Co. (Rahway, NJ)
- …the network. Incorporate relevant digital tools to automate and improve project/ program management efficiency where relevant.Cross-Functional Team Leadership: in ... efficiency and data-driven decision-making. Under the broad guidance of the DSCS Digital Program Mgmt Lead , the Associate Director, DSCS Digital Project Manager,… more
- Merck & Co. (Rahway, NJ)
- …relevant scientific discipline (Oncology preferred) or MD from a top ranked program , equivalent experience considered4+ years of strategy management consulting ... development, strategy execution and value realization, enterprise strategic planning, risk management , and strategic venture investments in healthcare as part of our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Execution Systems Lead and will be responsible for providing project management support to the development and administration of EBR and digital solutions at ... program plans. Having experience with global teams, budgetary management , resource planning, and fiscal awareness is preferred.Provide technical expertise of… more
- Merck & Co. (Rahway, NJ)
- …a best-in-class patient experience for IBD patients in support of the launch of our lead asset in immunology. This role will develop a deep understanding of the IBD ... collaborate closely with the US patient support strategy (PSP) lead where relevant, with an aim to ensure the...of IBD launchIdentify key elements of a patient support program to address these gaps in consideration of competitive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or learning management systems.Knowledge of cGMP ... an Operations Unit and collaborate closely with Operations Associates and Management to facilitate readiness of trainees and effective process qualifications. The… more
- Merck & Co. (Rahway, NJ)
- …with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of ... Demonstrated ability to develop talent through good mentoring skills. Experience with matrix management and peer to peer coaching - - - Demonstrated ability for… more
- Merck & Co. (Rahway, NJ)
- …Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP automation systems. Lead integration of control systems with MES, Quality , and Batch ... is capable of meeting all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot scale, small and large scale… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …solving program to improve safety, compliance, cost, process stability building quality and efficiency into processes to improve lead times and reliability ... cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead continuous improvement initiatives with various site functions to support of… more
- Wyndham Hotels & Resorts (Parsippany, NJ)
- …all Wyndham properties in accordance with brand standards and legal requirements. **Project Management :** + Lead special projects or initiatives assigned by the ... as it relates to driving revenue through the WH&R channels, revenue management standards utilizing WH&R available resources, offering guidance on initial set up… more
