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The VP CMC Regulatory & Quality will lead all aspects of CMC Regulatory Affairs to support global regulatory submissions as well as CMC Quality Assurance and Quality Control for Invivyd’s clinical candidates and commercial products.
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Director, AML Compliance ModelingBoston, United States of AmericaThe Director, AML Modeling is part of the Compliance Analytics team which is responsible for overseeing risk management strategies to prevent, detect and disrupt usage of Bank products and services for the purposes of money laundering, terrorist financing, bribery, corruption and economic sanctions avoidance.
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Rehab Systems Management Provides supervision in all areas of the Day Hab Systems reporting standards to ensure organizational compliance with all DMA, DDS regulations. He/she will coordinate all aspects of the Day Hab Systems reporting standards to ensure organizational compliance with all DMA and DDS regulations and have the ability to teach others and provide constructive feedback and supervision.
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PARKER CHOMERICS is a global supplier of EMI shielding, thermal interface materials, plastics and optical products. Experience leading SAP ME and/or SAP DMC project implementations Functional knowledge and hands-on experience with LIMS (Laboratory information management system), QMS (Quality management system), and MAM (Manufacturing asset management.
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The Principal Engineer will also lead timely risk identification, communication and resolution and work in close collaboration with Process Development and Clinical Supply (PDCS), Alexion Operations, Quality (QA), Regulatory (RA), Analytical Development Quality Control (ADQC) and internal and external Testing/Manufacturing sites.
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The key objectives of the Supplier Quality Manager include managing supplier management systems, including supplier quality manuals, procedures, and improvement activities.
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Create a culture of compliance internally and externally where everyone Lives Our Values Every Day (LOVED) and abides by Takeda’s Global Code of Conduct and Supplier Code of Conduct. Implement Procurement CoE-led strategic supplier management, supplier risk management, supplier diversity, and CSR programs within category while adhering to the CMO segmentation model.
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2+ years experience in metallurgical engineering within metals production or related sector Proficiency in materials characterization tools such as Inductively Coupled Plasma (ICP), X-ray Diffraction (XRD), Scanning Electron Microscopy with Energy Dispersive X-ray Spectroscopy (SEM/EDS.
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In this role you will manage the teams responsible for providing day-to-day support of the Quality Systems, Compliance and Supplier Quality functions. The Director, Quality Systems and Compliance provides strategic direction and oversight of the Quality Systems and Quality Compliance functions at ElevateBio to ensure execution and performance meets regulatory requirements and current industry best practices.
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Guides and ensures that the clinical study documentation (documents, images and other digital content) is correctly filed and archived, and that the study is maintained in a trial master file (TMF), so that documentation of GCP compliance is available, if required by a regulatory agency.
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We are seeking a highly motivated, experienced, and passionate individual to join our team as Pharmacovigilance Quality and Compliance Pharmacovigilance Coordinator at Ardelyx Inc. As a subject matter expert, you will play a pivotal role in ensuring the adherence of our pharmacovigilance activities to regulatory requirements, industry standards, company policies, and global regulations.
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These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research.
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Knowledge of Occupational Health, Worker’ Compensation System, OSHA, infectious diseases, wellness and regulatory compliance programs. MelroseWakefield Hospital and Lawrence Memorial Hospital are distinguished by the range of high-quality clinical care and services.
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The Quality Systems Lead is responsible for the quality operations and quality and regulatory compliance for MEDIPOST’s cell therapies from research through the clinic to commercialization, including the build-out of a phase-appropriate quality roadmap.
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Certified Hazardous Materials Manager (CHMM), Certified Safety Professional (CSP) and/or Certified Microbial Consultant (CMC) licenses. The ideal candidate should have excellent communication skills both verbal and written along with 10+ years of experience in the indoor air quality, industrial hygiene, safety and hazardous building materials industries, and be accredited as a Certified Industrial Hygienist (CIH.
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raw materials regulatory compliance supplier quality manager jobs Title: quality manager in Lincoln, MA
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