- Formation Bio (New York, NY)
- …you will establish and manage the organization to ensure our organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good ... to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support drug… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contribution to trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT), SCORE and other ... breaches of GCP. Triage, resolve or escalate study issues / risk mitigations as per JOC/ESC and other established forums....performance and management of 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and ... design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development, design verification and validation,… more
- Eisai, Inc (Nutley, NJ)
- …The Senior Director oversees vendor qualification, governance frameworks, and compliance with ICH/GCP guidelines and local regulations, ensuring inspection readiness ... Collaboration is central, working closely with Finance, Legal, Regulatory & Compliance , IT Security, and Clinical teams to align outsourcing strategies with… more
- Merck & Co. (Rahway, NJ)
- …to go live with new equipment and infrastructure (eg Quality risk assessment, safety assessment, data integrity, change management, etc.)Provide next-level support ... Company (eg our Company's Manufacturing Division) to build or risk -mitigate infrastructure Position Qualifications: Education Minimum Requirement: Bachelor's degree… 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
- Unknown (Dallas, TX)
- …Director of Global Pharmacovigilance to lead the development and implementation of risk management strategies and ensure compliance with all relevant regulations ... and guidelines. The successful candidate will be responsible for managing the pharmacovigilance team, overseeing the collection, analysis, and reporting of adverse events and safety data, and ensuring the timely submission of safety reports to regulatory… more
- Unknown (Erlanger, KY)
- …health, and safety matters. This includes incident investigation, regulatory compliance , legal guidance, risk management, training and development, ... issue resolution, policy development, and horizon scanning for changes in legislation and best practices. The role involves close collaboration with operational and commercial leaders, as well as other legal counsel, to ensure that the company's practices meet… more
- Unknown (New York, NY)
- …will oversee portfolio monitoring activities, including performance tracking, covenant compliance , borrower communications and risk assessment, while identifying ... and refinancing opportunities. Additionally, you will collaborate with legal, risk , and operations teams, maintain strong relationships with borrowers, sponsors… more
- Northrop Grumman (Linthicum Heights, MD)
- …suite that allows for speed, productivity and integration while facilitating compliance and focusing on program execution. The Principal Planner/Scheduler is ... building role that provides exposure to contract management, production operations, risk and opportunity management and program management practices. The ideal… more
