- 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
- 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
- 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
- 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
- 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)
- …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
- 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
- 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
- Merck & Co. (Durham, NC)
- …safety programs such as Lock Out/Tag Out (LOTO), Hazardous Energy Control Procedures (HECP)Collaborates with the Technical Center of Excellence (CoE) Reliability ... Engineers to conduct periodic Risk Based Asset Management (RBAM) assessments and own area...actions and preventive actions (CAPA)Ensure accurate MTTR and MTBF data collectionEstablish and lead the condition monitoring strategy of… 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
- 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
- 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
- Nevada System of Higher Education (Las Vegas, NV)
- …tailored to identified risks. Provide independent and objective assessments of risk management, governance, and financial control processes. Recommend actionable ... and advisory services that evaluate and improve the effectiveness of risk management, internal controls, compliance, and governance processes across NSHE… 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
- Stanford University (Stanford, CA)
- …and processes to ensure data quality, integrity and security of systems and data appropriate to risk . * Participate in and/or contribute to setting strategy ... (eg, Git) and containerization tools (eg, Docker). * Familiarity with healthcare data standards and regulatory requirements. EDUCATION & EXPERIENCE (REQUIRED):… more
- First Horizon Bank (Knoxville, TN)
- …service to internal and external clients. Responsible and accountable for risk by openly exchanging ideas and opinions, elevating concerns, and personally ... in departmental projects that ensure unit contingency planning and regulatory compliance. Essential Duties and Responsibilities: Candidate should have in-depth… more
- NorthMark Strategies (New York, NY)
- …of OCIP insurance programs, ensuring optimal coverage, compliance, and cost control . Analyze and evaluate alternative risk transfer opportunities, including ... and incident reporting, supporting continuous improvement and cost containment. Monitor regulatory developments impacting insurance and risk transfer programs,… more
