- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance position is ... Quality management system. This role is responsible for Good Clinical Practice ( GCP ) oversight, and for assuring the compliance of projects, products and programs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports ... guides. Participates in inspection preparation activities and internal and external audits and audits CAPA preparation.Case Processing Training: Identifies case… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for projects/studies. This position has sufficient understanding of regulations and GCP requirements for drug development, advanced knowledge of Electronic Data ... Management leader representing R&D during regulatory inspections and internal audits pertaining to R&D activities. Operational Efficiency / Continuous… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for projects/studies. This position has sufficient understanding of regulations and GCP requirements for drug development, advanced knowledge of Electronic Data ... Management leader representing R&D during regulatory inspections and internal audits pertaining to R&D activities. Operational Efficiency / Continuous Improvement:… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and regulatory requirements. + Execute the strategic audit plan. Plan, schedule, and conduct GCP audits in accordance with the audit plan. + Prepare and deliver ... compliance, pharmacovigilance, or a related field. + Extensive experience leading GCP audits , in the biopharma or related industry. + Expert knowledge of… more
- System One (Tarrytown, NY)
- Job Title : Temp - Associate Director , Aggregate Reporting, GPS Type: Contract Compensation: $85 - $100 hourly (dependent on experience) Contractor Work Model: ... Interaction & Inspection Readiness + Participation in regulatory inspections or audits focused on pharmacovigilance. + Preparation of documentation for FDA, EMA,… more
- HistoWiz (Long Island City, NY)
- …to support our customers' growing histology needs. Who are you? The Senior Manager/ Director of Quality is responsible for overseeing the quality and compliance of ... management system in accordance with the GLPs. Leads internal audits and hosts client audits . Responds to...experience + In-depth knowledge and experience with GLP and/or GCP regulations and industry standards (EPA, OECD, FDA, EU… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- As a Senior Director of IT, Quality Assurance and Compliance, you will lead a team of those managing 20 to 30 members The focus is to provide leadership, coaching, ... management of our Health Authority, agency and internal company audits . Ensure all IT-related aspects are in compliance and...* Ensure compliance with all GxP regulations, including GMP, GCP , and GLP, SOX, and other compliance requirements, across… more
- JPMorgan Chase (Jersey City, NJ)
- …produce quality deliverables to both department and professional standards, while ensuring audits are completed timely and within budget. + Work closely with global ... in the program of audit coverage. + Assist in all aspects of audits including risk assessments, audit planning, audit testing, control evaluation, report drafting… more
- CUNY (New York, NY)
- …Management (SCM) and File Integrity Monitoring (FIM). Reporting to the Director of DevSecOps, the engineer will contribute to Network Automation, Centralized ... including PCI DSS, HIPAA, FERPA, and GDPR, by participating in security audits , risk assessments, and implementing necessary controls. + Develops and reviews… more
