- Legend Biotech USA, Inc. (Raritan, NJ)
- …to prioritize investigations based on potential impact on product quality, patient safety , and regulatory compliance . Address recurring deviations and ... myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based… more
- UT Health Tyler (Tyler, TX)
- …Education: Provides education to focus areas regarding Quality Monitoring and Improvement, Regulatory Compliance , Patient Safety , Risk Management, Medical ... and makes recommendations for system improvements using quality data, event and regulatory compliance reports. Provides project management to assigned teams by… more
- Merck & Co. (Rahway, NJ)
- …that all team activities are completed with the highest regard for safety , quality and regulatory compliance .Qualifications:Education Minimum Requirement: ... and characterization, scale-up and activities to support technology transfer and regulatory filings. They are responsible for the management and development of… more
- Merck & Co. (Rahway, NJ)
- …ensures that all team activities are completed with the highest regard for safety , quality and regulatory compliance .Qualifications: Education: Degree in ... pilot plant scale-up and activities to support technology transfer and regulatory filings. The incumbent will be responsible for the performance and… more
- Merck & Co. (Rahway, NJ)
- …an effective implementation and oversight model to maintain best-in-industry regulatory compliance .The Vice President Regulatory Affairs, ... contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function...in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing… more
- Merck & Co. (Rahway, NJ)
- …to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company… more
- Catalent (St. Petersburg, FL)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent ... Compliance ManagerPosition SummarySt. Petersburg is our primary softgel...readiness. Assess changes to GxP systems and data integrity regulatory requirements and communicate requirements to site leadership.Review and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Overview The Quality Compliance - Lead Auditor CAR-T is responsible for regulatory compliance supporting the production of autologous CAR-T products for ... independent audits; manage audit responses and observation resolution. Drive site compliance to regulatory , enterprise, and global requirements through building… more
- Merck & Co. (Rahway, NJ)
- …Division, and Global Workplace & Enterprise Services (GWES) to ensure compliance with regulatory requirements, corporate standards, policies and procedures ... with regulatory agencies.Demonstrated skills in complying with one or more regulatory programs: RCRA, Title V, Process Safety Management (PSM), Industrial… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … risks.Conducts safety training sessions for employees and vendors. Ensure compliance with all regulatory bodies and standards (including OSHA, EPA, NCDEQ, ... Position Summary The Environmental, Health & Safety (EHS) Specialist will ensure compliance with all laws, regulations, applicable codes, and policies pertaining… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Sazerac Company (Louisville, KY)
- …implement new initiatives including package changes.Works with site leadership to ensure compliance with safety , regulatory and environmental requirements ... culture of employee engagement to drive improvements. Job Description/Responsibilities: Design safety into all new bottling installations. Develop SOPs for all… more
- Catalent (Philadelphia, PA)
- …material management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA ... a Patient First culture through excellence in quality and compliance , and to the safety of every...Distribution Summaries/Checklists, and Returns Protocols (as required). Audit for compliance as pertains to Catalent SOPs, regulatory ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and execution of clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. In this high visibility position, the ... Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preventative maintenance (PM) & predictive maintenance (PDM) practices to ensure compliance (cGMP) with company policies and appropriate regulatory standards ... Partner and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelines Develops metrics… more
- Merck & Co. (Durham, NC)
- …qualification activities while ensuring product quality and optimized maintenance processes, regulatory compliance , employee and environmental safety , ... for the daily support of all production equipment to ensure area safety , compliance , production and financial goals are metSupports the reliability… more
- Merck & Co. (Rahway, NJ)
- …all functions of our company while driving improvements and alignment for regulatory compliance worldwide.Responsibilities: Manage and provide leadership to a ... direction on future-driven initiatives related to Product Stewardship and compliance .Oversee the chemical management systems, hazard communication ( Safety … more
- Merck & Co. (Durham, NC)
- …own unit. Compliance - Creating and sustaining a culture that ensures that compliance ( Safety , Environment, cGMP, etc.) are imperatives for the business - ... a quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing… more
- Merck & Co. (Durham, NC)
- … - Responsible for creating and sustaining a culture that ensures that compliance ( Safety , Environment, cGMP, etc.) are imperatives for the business.- ... with a team of individual contributor production direct reports including safety , quality, and daily operations;Ensure that Shift(s) objectives are achieved while… more
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