- Delek US Holdings (Dallas, TX)
- …Affairs & Compliance Specialist + Job Code: 20001259 + Job Family: Legal, Compliance , & Risk Management + FLSA Status: Exempt + Job Function: Regulatory ... relationships with regulatory commissions/authorities related pipeline. Coordinates and conducts the assessment of internal controls to ensure compliance as… more
- Formation Bio (New York, NY)
- …guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment and management methodologies, with a successful track ... you will establish and manage the organization to ensure our organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good… more
- Eisai, Inc (Nutley, NJ)
- …performance and reduce potential risks.Oversees vendor qualification and collaborate with Vendor Risk Assessment teams to ensure vendor strategies comply with ... The Senior Director oversees vendor qualification, governance frameworks, and compliance with ICH/GCP guidelines and local regulations, ensuring inspection readiness… more
- Merck & Co. (Rahway, NJ)
- …Medical Supply Management, Motivating Teams, Negotiation, Operational Excellence, Operational Risk Assessment , Outsourcing, People Leadership, Problem Solving, ... supplies to clinical sites across more than 60+ countries, in compliance with worldwide regulations, company policies and standard operating procedures.The Director,… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …or lead preparation of regulatory submissions (eg, pre-IND, IND, BLA).Contribute to risk assessment of new and ongoing programs, including off-target effects, ... strategic Senior Director of Toxicology to lead and oversee all nonclinical safety assessment activities for our cell and gene therapy programs. This individual will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …certification program to ensure adequate qualification of auditors per regulatory expectations. Risk Management and Vendor Performance: Responsible to ensure the ... risk management activities completion for vendors and to periodically...meet DS company expectations and to support the strategical assessment of suppliers prior to selection and contract.Development of… more
- Cipla (Hauppauge, NY)
- …qualifying manufacturing equipment (IQ, OQ, and PQ) and preparing necessary PQ protocols. Risk assessment and risk mitigation by performing FMECA (Failure ... (batch records, logbooks, SOPs, etc.) following cGMP standards to ensure compliance with written procedures. Monitoring production processes to acquire vital data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations from end to end.Ensure thorough root cause analysis, impact assessment , and CAPA/EC determination.Work cross functionally with SME's and Quality to ... ensure robustness of investigations, as well as accuracy and ensuring compliance .Support and manage change controls and maintain permanent inspection readiness and… more
- Merck & Co. (Boston, MA)
- …development, strategy execution and value realization, enterprise strategic planning, risk management, and strategic venture investments in healthcare as part ... and leaders to identify high-value strategic imperativesLead the framing, assessment , and recommendation of key initiatives in collaboration with executive… more
- Battelle Memorial Institute (Boston, MA)
- …profitability in areas such as, environmental remediation, PFAS mitigation, ecological risk assessment , environmental compliance , marine studies, ... sustainability consulting and climate resilience. This position offers flexibility for remote work within the United States, with travel to client sites, conferences, and Battelle offices as needed. **Responsibilities** + Develop and execute a targeted… more
