- 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
- 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
- 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
- Merck (Rahway, NJ)
- **Job Description** The Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope ... for GCTO country operations. Adherence to GCP , local and global policies and procedures to conduct...level operational study budgets. + Regulatory Inspections and internal audits ; responding to inquiries by health authorities, ethics committees,… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Director , Quality Risk Management will drive consistent Global Leadership on ... the GxPs (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP) across the Product Lifecycle. Accountable to...BMS network. This position will report into the Senior Director , Risk Management. **Key Responsibilities:** + Provide strategic and… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- **Job Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for ... a leadership position in the conduct of clinical facility and system audits at all relevant facilities, investigator sites, and vendors (including contract research… 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
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Interpret and communicate regulatory requirements to internal stakeholders. + Participate in internal audits to ensure compliance with GMP, GCP , GLP, and other ... Description: The Director , Quality Management System is responsible for standardization...and implement corrective and preventive actions. + Support external audits and inspections from regulatory agencies. Co-ordinate with site… 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
