- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality ,...include new ways of working with existing or new systems (eg, Vault RIM)Work with GRA stakeholders to define… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and customer focus, for supporting and upholding processes anchored in the NN Quality Management System (QMS) across NAO thereby ensuring highest quality ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and internal stakeholders to execute audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, ... quality improvement initiatives for development activities / programs post internal system audit.Support reporting of quality metrics for audits and… more
- Merck & Co. (Rahway, NJ)
- …findings during documentation reviews. Collect, prepare and analyze data to support quality system metrics and planning. Support compliance activities such as ... all API are manufactured in compliance with cGMP and regulatory filings. Perform independent quality review and...ensure practices are accurately reflected. Assist in SOP and quality -related system document approval. Support metrics by… more
- Merck & Co. (Rahway, NJ)
- …Payments Manager will help lead the strategic direction, operational quality , and innovation of the credit union's payments ecosystem, including card services, ... critical role in driving member satisfaction, improving efficiencies, and ensuring regulatory compliance while advancing the credit union's payments strategy in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the management of ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… more
- Repligen (Waltham, MA)
- …in conducting risk assessments and quality audits. Experience with eQMS systems or digital audit tools Familiarity with regulatory standards (FDA, GMP, ... manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate… more
- Aequor (Thousand Oaks, CA)
- …plates. Working in a laminar flow hood. Work with Laboratory Information Management System (LIMS) and/ or SmartLab (LMES) with efficiency and accuracy. Job Summary ... This position is a unique opportunity to work within Quality Control at the Thousand Oaks site and to...SOPs and enter results in a laboratory information management system (LIMS) and/ or SmartLab (LMES). This position will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related to US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent Acquisition functions ... and continually improve data representation and delivery applications (including data quality ) in support of US Talent Acquisition Evaluates processes within Talent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Merck & Co. (Durham, NC)
- …CMMS system platforms and route engineering change requests through CMMS system .Expand knowledge into other systems , capable of managing change in the ... Durham sites.- This includes Energy Center, Vaccines Manufacturing and Bulk Facilities, Quality Labs, and Maintenance and Material Storage Facility (MMSF). At times,… more
- Aequor (Thousand Oaks, CA)
- …, and procedures. Interfaces across functions including Supply Chain, Manufacturing, Finance, Regulatory , and Quality at various level of detail, to advice ... EOD Weds 7/23 Standard business hours Supply Chain Senior Manager - Global Supply Chain Leader What you will...and technical advice on global supply chain processes and systems . Responsible for full Value Stream Mapping of all… more
- Twist BioScience (South San Francisco, CA)
- …by collecting, analyzing, and summarizing information and trendsWrite/review product quality documentationFollow regulatory and ISO 13485 requirementsWhat You'll ... He/she will work closely with the operations team to monitor the quality of Twist DNA products utilizing quantitative measurements, fragment analysis, NGS… more
- Merck & Co. (Durham, NC)
- …and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director).-This role ... serves as a Virtual Plant Manager - responsible for leading a cross-functional team in...Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... Engineer to support the bulk process tableting line. This role will improve/develop systems & equipment for the core processes to meet all customer, business &… more
- Cole-Parmer (Franklin, MA)
- Job Title: Sr. Manager , Quality and Regulatory Assurance Reports To: VP, Quality Position Location: Franklin, MA FLSA Status (Exempt/Non-Exempt): FLSA ... Status: Exempt Position Summary: The Senior Manager , Quality and Regulatory Assurance...quality standards + Ensure company compliance with accredited quality systems : 21 CFR part 820, ISO… more
- Tecomet (Woburn, MA)
- … Systems . + Responsible for managing multiple sites to encompass global Quality Systems and Regulatory Affairs responsibilities. + May have Senior ... **TITLE** : Quality Assurance & Regulatory Affairs Manager **Department:** Quality...essential) + Ten (10) to Fifteen (15) years of regulatory affairs and quality systems … more
- Safran (Grand Prairie, TX)
- Quality Regulatory Manager Company : Safran Helicopter Engines Job field : Quality Location : Grand Prairie , Texas , United States Contract type : ... (SafranHE USA) in Grand Prairie, Texas is hiring a Quality , Safety, and Regulatory Manager ...years of cumulative industry experience in Aerospace, Safety Management System deployment, Quality Management Systems ,… more
