- Novo Nordisk Inc. (Plainsboro, NJ)
- …execute and deliver clinical studies/programs on time with a focus on budget, compliance and quality . Leads strong and effective communication to global and ... interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to...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)
- …Director. Interacts with colleagues within Patient Support Programs, Patient Safety, Quality , NNI IT and Telephony, Medical Information, Compliance , Regulatory, ... Partners with PSS Program Management team to ensure vendor compliance with all quality /safety requirements; educates on...safety information related to Novo Nordisk products and in compliance with Novo Nordisk and FDA requirements… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the ... essential to an effective functioning of the various subunits of the Quality System and ensuring accountability. Achieving compliance with cGMP and… more
- Aequor (Thousand Oaks, CA)
- …(R&D, Operations, and GCO). In this vital role you will support the quality management system team to provide proactive compliance oversight to processes, ... Does the thought of building an entirely new digital quality management system, excite you? Do you love to...Management System Requirements, Product Standards / Regulatory Requirements (eg FDA CFRs for Biologics and Medical Devices, FDA… more
- Merck & Co. (Durham, NC)
- …own work group or potentially impact product dispositionInfluence and Decision Making:Represents Quality in the laboratory to influence cGMP compliance and ... finished product, and laboratory testing for the BCG vaccine.The Senior Specialist, Quality Control participates in a team of analysts in the development,… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes ... tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …track, store, and disseminate critical CMR training documentation Ensures training and compliance to FDA Regulations, ICH Guidelines, and GCPs governing the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....cross-functionally are essential Knowledge and understanding of GxP training compliance , FDA Regulations, ICH Guidelines, and GCPs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes ... of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV) service ... and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the release of drug products for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, ... tasks required to meet business objectives.Support Investigations team by providing quality and compliance input for continuous improvement; and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... Independently leads cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategizes and plans for FDA … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sites to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance . Proactively track, monitor and report trial ... interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and business as usual.Leads or assists in the tracking and investigation of quality and compliance issues OtherReview and update of DMA ProceduresMaintain ... supporting documents and evidenceSupport with implementing and ensuring global DBMA quality standards for Change requests IT Vendor Oversight and ManagementManaging… more
- Merck & Co. (Durham, NC)
- …own work group or potentially impact product dispositionInfluence and Decision Making:Represents Quality in the laboratory to influence cGMP compliance and ... active ingredient, finished product, and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager leads a team of analysts in the start-up… more
- Merck & Co. (Rahway, NJ)
- …strategy.Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… more
- Aequor (Chattanooga, TN)
- …safety requirements, Standard Operating Procedures (SOP's), Good Manufacturing Practices (GMP) Compliance , and Food and Drug Administration ( FDA ) regulatory ... Managing and Measuring Work, Process Management, Problem Solving, Decision Quality , Customer Focus, Integrity and Trust, Listening, Peer Relationships, Directing… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe QC Chemistry Finished Product Supervisor will report directly to quality upper management, (QC Senior Manager), and will provide both managerial ... ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …or Automotive production, leadership skills, and a commitment to excellence in quality and safety. The Plant Manager will be responsible for ensuring efficient ... Management: Oversee all aspects of plant operations, including production, quality control, maintenance, and shipping.Team Leadership: Manage, mentor, and develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the oversight, performance and management of CROs and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of ... appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH)… more
