- Formation Bio (New York, NY)
- …with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating risks before they ... 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)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Formation Bio (New York, NY)
- …regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment ... will have the opportunity to establish the strategic development and operational management of Formation Bio's quality assurance program to support the growing drug… more
- Merck & Co. (Rahway, NJ)
- …Auditing and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below ... and be decisive in an ambiguous environment.Experience and ability to achieve compliance goals through a risk -based approach with a deep understanding… more
- Merck & Co. (Rahway, NJ)
- …point for the docketing team, attorneys, and staffImmediately reports all risk management -related concerns to Senior LeadershipResponsible for the compilation ... Office Suite (Outlook, Word, Excel and SharePoint) and Adobe Acrobat ProStrong project management skills, including the ability to lead and oversee complex… more
- Merck & Co. (Rahway, NJ)
- …, Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance , Risk Management , Stakeholder ManagementPreferred Skills: Current ... you'll be a core member of the Value Chain Management Team, guiding strategy, ensuring compliance , and...with site quality teamsRepresent Quality on the Value Chain Management Team and related working groups; lead … more
- Merck & Co. (Rahway, NJ)
- …Key Results (OKRs), Pathway Analysis, Pharmaceutical Sciences, Process Leadership, Product Management , Rapid Prototyping, Risk Management Framework, ... team in our Company's R&D IT brings together product management , engineering, and data science expertise. We enable data,...RaDS Product organization. The position will report to the Lead of the Disease Biology and PharmTox Product Line.… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment, risk ... thermal and distribution qualification for pharmaceutical products.Strong understanding of risk management principles.Strong strategic and analytical thinking,… more
- Principal Financial Group (New York, NY)
- …stakeholders, including compliance , internal audit, fund administration, and enterprise risk management . + Partner with client-facing teams and sales ... + Support mindset shifts within the business toward proactive risk ownership-helping teams move from compliance -driven activities...in or lead special projects that strengthen risk management capabilities across Principal Asset … more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… more
- ValSource, Inc. (Rahway, NJ)
- …is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting ... with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management : Interface with clients, lead teams of validation professionals,… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social Collaboration,… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... and external stakeholders. Required Skills: Biopharmaceutics, Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness,… more
- RGP (New York, NY)
- …and forward thinking. + Lead and manage client engagements focused on risk management , regulatory compliance , and audit remediation across banking, ... Senior Manager within our Risk & Regulatory Compliance practice. Our Senior Managers lead teams...a strategy consulting firm (required). + Extensive experience in risk management , regulatory compliance , and… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutical Industry, Capital Project Management , Capital Projects, Change Management , Cybersecurity Risk Management , Data Analysis, Deviation ... operations (FLEx) and new capital builds, including automation lifecycle management , data/analytics, and site representation on capital projects.- Some off-shift… more
- SMBC (New York, NY)
- …team. This role will support CCAR and credit stress testing, and will play a lead role in project management across these workstreams. The ideal candidate will ... high-quality results in a fast-paced environment. Responsibilities **Role Responsibilities** Project Management - Lead and coordinate credit stress testing… more
- Merck & Co. (Rahway, NJ)
- …strategy development, strategy execution and value realization, enterprise strategic planning, risk management , and strategic venture investments in healthcare ... Consulting, Collaborating, Communication, Data-Driven Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management… more
- Merck & Co. (Rahway, NJ)
- …Intelligence (BI) Desktop, Natural Language Processing (NLP), Python (Programming Language), Risk Management , R Programming, Science, Scientific Literacy, Trade ... Data Analyst to support the R&D efforts related to the Insider Risk /Trade Secret (IR/TS) program through advanced data analysis and strategic collaboration. This… more
- Merck & Co. (Rahway, NJ)
- …and microbiological release of pipeline products.- The director will provide guidance, lead activities, and strengthen a team of microbiologists whose roles include ... in commercialization and manufacturing in aspects of quality control, compliance , and strategic partnering. Primary Responsibilities: Reports to the Executive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... contracting and recommend best practices and solutions Proactively conduct comprehensive risk assessments to identify potential legal and operational risks within… more
