- Merck & Co. (Rahway, NJ)
- …and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods images ... development and technology teams, supply chain, operations, quality, analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership… more
- Merck & Co. (Rahway, NJ)
- …and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process ... Control , Manufacturing Scale-Up, Mentorship, Process Improvements, Protein Purifications, Regulatory Submissions, Technical Writing, Technology TransferPreferred Skills: Current Employees… more
- Merck & Co. (Rahway, NJ)
- …and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods images ... development and technology teams, supply chain, operations, quality, analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution across Medical Affairs programs, ensuring compliance with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the ... Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams (eg, Medical Safety, Regulatory Affairs, Epidemiology) to ensure benefit- risk integration to ensure signal, epidemiological data , and regulatory ... processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement… more
- Revel IT (Tucson, AZ)
- …ensure optimized value delivery. You will be the single point of contact and control for project and program data collected from the functions. Manage ... Phased Development processes Profound understanding and knowledge of healthcare quality, risk , and/or regulatory compliance Demonstrate good strategic and… more
- Insmed Incorporated (NJ)
- …throughout their lifecycle, ensuring compliance with FDA, EMA, and ICH regulatory requirements. This role will support implementation and ongoing management of ... digital systems used in clinical trial operations, quality control laboratories and other GxP areas, with a focus...laboratories and other GxP areas, with a focus on data integrity, validation, and inspection readiness. The Sr. Quality… more
- Insmed Incorporated (NJ)
- …external partners. The position is critical in shaping quality strategy, managing risk , and supporting regulatory readiness for complex, evolving pipelines.What ... vendor management experience.Proven expertise in root cause analysis, investigations, change control , and Quality risk management.Direct experience with clinical… more
- Merck & Co. (Rahway, NJ)
- …Customer-Focused, Data Analysis, Driving Continuous Improvement, Financial Risk Management (FRM), Inventory Control Management, Key Performance ... global filing and launch strategy, long-range demand vs capacity planning, integrated risk management, cost of goods projections, post approval change management and… more
- Merck & Co. (Rahway, NJ)
- …and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make ... experiments to create effective shipping solutions to maintain temperature control and physical protection.Provide subject matter expertise and ensure scientific… more
- Insmed Incorporated (NJ)
- …documents (ie Joint Operating Guidelines, Quality Management Plans, Safety Data Exchange Agreements).Participates in Regulatory Authority inspections and ... Quality Assurance serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related… 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 ... Company and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs… more
- Aequor (Irvine, CA)
- …a variety of audiences within the organization Proficient in project management, data analysis, root cause analysis, communication, and risk determination Ensure ... shift The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices.… more
- Aequor (Cincinnati, OH)
- …management, line reviews, etc. Support for foreign material decision making and risk assessment. Learn and understand regulatory and food safety requirements ... with Logistics department. Allergen inspection leadership and documentation Auditing HACCP, Control Point, and Control Measure documentation for compliance… more
- Merck & Co. (Rahway, NJ)
- …Procurement Strategies, Production Planning, Project Management, Project Procurement Management, Regulatory Compliance, Risk Management, Strategic Procurement {+ ... sourcing and contracting execution, contract and claims management, project and risk management practices, and supplier relationship management, all in alignment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …are executed in an effective, efficient, and compliant manner.Participate in Risk Assessments, FMEAs, and system/ data process mapping activities.Execute, own, ... 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… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream processes by increasing ... prioritization, and problem-solving skills.Stay updated on the scientific and regulatory landscape; contribute scientifically and build your reputation through… more
- Citigroup (Tampa, FL)
- We are seeking a highly organized and detail-oriented Regulatory and Risk Data Analyst to join our team. This role focuses on managing, analyzing, ... visualizing, and monitoring regulatory and risk data to...owned by CBNA Head Office. + **Maintenance of Reference Control Operations changes** : Support the CBNA Tier 1… more
- Deloitte (Jersey City, NJ)
- …Developing and implementing regulatory reporting policies, including risk and control assessments, operational and data controls, and data analytics ... 009, or FFIEC 101 + Understanding of business processes, regulatory requirements, risk management, internal control... regulatory requirements, risk management, internal control management, process, data and technology controls,… more
- Charles Schwab (Southlake, TX)
- …operational related industry best practices and regulatory requirements. + Proficiency in risk and control data analysis, strong ability to incorporate ... as well as testing the design and effectiveness of controls across the Company's Risk and Control Self -Assessment (RCSAs). This role will lead testing projects… more
