- Tris Pharma (Monmouth Junction, NJ)
- …Documentation Practices (cGDPs) within pharmaceutical industryExperience implementing and managing quality systems and processesFamiliar with US FDA guidance ... Junction, New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS)… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the Quality Department in developing and ... Position Summary:The Quality Execution Counsel is a managing member of...uniquely Exela's way. Job Responsibilities: Drafting, editing, and reviewing FDA -issued regulations and Guidance documents, as well as internally… more
- Merck & Co. (Upper Gwynedd, PA)
- …DescriptionIt is business critical that our Company receives consistent, accurate, high- quality data from clinical trials conducted worldwide. In collaboration with ... the Clinical Quality Operations Lead {CQOL and Head of Clinical ...the United States of America Food and Drug Administration ( FDA ), European Medicines Agency (EMA), UK Medicines and Healthcare… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director, Device Quality & Regulatory will play a pivotal leadership role within the organization, overseeing the quality assurance ... combination products. This role ensures the highest standards of device quality throughout the product lifecycle, from design and development to commercialization.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....in Advertising and Promotion. The fellow will learn about FDA regulations, including compilation and submission of any required… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the Quality Department in developing and ... Quality Execution CoordinatorPosition Summary:The Quality Execution... infrastructure in a uniquely Exela way.Job Responsibilities: Reviewing FDA -issued regulations and Guidance documents, as well as drafting,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....contracts with safety reporting requirements. Key contact person for FDA and Health Canada PV inspections and device inspections… more
- Merck & Co. (Durham, NC)
- Job DescriptionResponsibilities: Responsible for the quality aspects of good manufacturing practices (GMP) computerized systems and the supporting infrastructure ... company policies, procedures, and regulatory expectations. Be involved in all quality -related activities for computerized systems which are required by the company… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to ... meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the Quality team based ... in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and Strategy role is an exempt...Sigma Certification is a plus.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... records. Will be a QA presence on the manufacturing floor. Relationships Quality Assurance. Essential Functions Reviews all manufacturing and support records to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....participate in project teams Assist with technical preparation for FDA meetings, including review of draft questions and supporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manner and continuous RPM process improvement with focus on quality , reliability, consistency and efficiency.ResponsibilitiesPlan, coordinate, and review US ... etc.).Develop less complex Module 1 regulatory documents (eg cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to ... meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and ... Independently lead cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategize and plan for FDA … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise ... plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …our company regulations and other global health authority regulators such as FDA . Will collaborate cross functionally to close nonconformance records and identify ... in preparation for and during internal and external regulatory audits (including FDA , EMEA).Support coordination of data collection and trend analysis as requested… more
- Tris Pharma (Monmouth Junction, NJ)
- …in-house analytical capabilities, when needed. The incumbent ensures timeline, quality and compliance with applicable Standard Operating Procedures (SOPs)/current ... packages per International Council for Harmonization (ICH)/Food and Drug Administration ( FDA ) guidance and provides technical guidance within and outside R&D for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support to the investigators and ... aimed at improving compliance and reducing repeat occurrences ensuring consistent quality standards are maintained.Key Responsibilities Support area Manager and work… more
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