- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders.SummaryAccountable for supporting and managing the Quality Management System (QMS) in accordance with regulatory requirements and ensuring ... ensure compliance with global and harmonized Quality Standards and regulatory requirements for the GMP area.Additional responsibilities include:Creating and… more
- Merck & Co. (Rahway, NJ)
- …development teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager ( Program CSPM) serves as ... key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory...program (s) . - Works directly in the SAP system to establish a consolidated , visible forecast for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position ... of facility and equipment for new projects and existing qualified systems within cell therapy manufacturing. The Commissioning and Qualification Project … more
- Insmed Incorporated (Phoenix, AZ)
- …standards and that all patient records are accurate and compliant with regulatory requirements.CRM System Subject Matter Expert (SME)Act as Subject Matter ... Workplaces™ lists.OverviewWe seek a dynamic and highly organized pharmaceutical Manager , Patient Services Operations to assist Patient Services leadership team… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The Programming Manager , Clinical Programming is responsible for ensuring integrity, consistency and adherence to Study ... objective of data quality and consistency across programs and systems . This role reports to the Director, Team Lead...(SDTM) standards that support the scientific need of a study/ program while ensuring quality, consistency and compliance to CDISC… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... The Position Manage operation & maintenance of facility & utility systems . Manage Facilities staff. Collaborate with cross-functional teams. Manage service &… more
- Novo Nordisk Inc. (Boulder, CO)
- …for patients. The Position Novo Nordisk is seeking a Quality Control Manager to support the successful start-up of the Quality Control laboratory supporting ... phase 1 and 2 oligonucleotide drug substance manufacturing. The QC Manager position will manage all activities related to the establishment & operation of the… more
- Novo Nordisk Inc. (Boulder, CO)
- …interacts with QA, QC, Internal Chemical Development, Drug Product Manufacturing, Program Management, CMC Regulatory , Manufacturing Operations, and Contract ... processes and develop appropriate mitigation plans Coordinate with QA, regulatory , and analytical development to determine documentation for RNAi programs… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and subject matter experts to prepare for FDA and other agency auditsEnsure site/ system validation program meets FDA, ISO and EU requirementsCollaborate with ... Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … systems Experience with Computerized Maintenance/Metrology Management System (CMMS) systems (Blue Mountain Regulatory Asset Manager (RAM), SAP, or ... Lebanon, NH bioproduction facility. Relationships Reports to: Facilities and Maintenance Manager . Essential Functions Serves system administrator for the CMMS… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Site Calibration Manager is a member of the Engineering, Maintenance and Site Services (EMSS) team providing oversight to calibration employees ... and the calibration program at the Durham Site.- This includes Energy Center,...This position will focus on managing calibration technicians, ProCal System Oversight and assisting with successful execution of calibration… more
- Novo Nordisk Inc. (Durham, NC)
- …Support validation activities associated with changes to existing & new systems . The incumbent will set requirements, build/construct, design, commission & perform ... for projects according to science & risk-based validation (SRV). Relationships Manager , Process Support - OFP. Essential Functions Participate & provide feedback… more
- Novo Nordisk Inc. (Boulder, CO)
- …Novo Nordisk against Custom's fines and penalties. This role ensures regulatory requirements are adhered to and proper documentation, including transit documents ... lead process improvements. Relationships This position will report to the Senior Manager , Materials Management. Essential Functions Primary point of contact for all… more
- Colorado Springs Utilities (Colorado Springs, CO)
- ** Regulatory Compliance Program Manager (Gas Compliance)** Job Type: **Business Operations** Pay Range **$129,000 to $162,000** Location **Colorado Springs, ... after a minimum of 5 days of being posted._ ** Regulatory Compliance Program Manager (Gas...utility sector leader in reliability, safety, workforce development, and system improvements + Located at the base of the… more
- Meta (Seattle, WA)
- **Summary:** The Regulatory Readiness Program Manager will develop and scale Meta's Regulatory Readiness processes. This role is pivotal in ensuring that ... develop, coordinate, and execute compliance solutions for Meta's products. **Required Skills:** Regulatory Readiness Program Manager Responsibilities: 1. … more
- Philips (Cambridge, MA)
- The Regulatory Affairs Program Manager will play a critical role within Philips Patient Safety & Quality Organization, responsible for enhancing tracking and ... controlling systems to optimize regulatory compliance monitoring and...and drive sustainable results. + Leads programs/projects focused on regulatory compliance with UDI requirements, Computer System … more
- Applied Materials (Austin, TX)
- …Management Professional (PMP), Program Management Professional (PgMP), and Certified Regulatory Compliance Manager (CRCM) are highly desirable. **Years of ... seeking a highly skilled and experienced PMO Professional to support our Product Regulatory Compliance program . This critical role ensures our products meet all… more
- Qualtrics (Chicago, IL)
- …Join over 6,000 people across the globe who think that's work worth doing. ** Manager , Provider Regulatory Program Management** **Why We Have This Role** ... management and compliance of CAHPS (Consumer Assessment of Healthcare Providers and Systems ) programs, which are crucial for assessing the patient experience in… more
- Google (Atlanta, GA)
- …for everyone, whether down the street or across the globe. As a Program Manager at Google, you'll lead complex, multi-disciplinary projects from start ... in program or project management. + Experience with hardware regulatory compliance and related SOX controls + Experience with data analytics. Preferred… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Learn more about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Regulatory Affairs (RA) Program Manager Digital Strategy ... across the Digital Unit (DU) including establishment and assessment of appropriate regulatory strategies and regulatory requirements. The Digital Unit is a… more
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