- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems , including ... investigation/deviation management, CAPA tracking, change control, risk management, supplier quality , audits and inspections, raw materials release, and compiling,… more
- Eisai, Inc (NJ)
- …and compliance with global and regional processes.Ensure contract tracking systems and databases updated with relevant information by the Outsourcing team in ... want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support...providers for Eisai's R&D functions. This role will ensure compliance with key processes and manage the outsourcing team.… more
- Merck & Co. (North Wales, PA)
- … Management System (QMS) elements, procedures, and systems to ensure quality and regulatory compliance with Current Good Manufacturing Practices (CGMPs), ... of New Modalities pipeline products to global markets.-Evaluate current and partner Quality Management Systems for seamless integration and realize synergies… more
- Catalent (Philadelphia, PA)
- …of the Clinical development supply division. This individual will have responsibility for Quality aspects related to Quality Systems , Finished Product Batch ... Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality...guidance to the Quality Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality… more
- Tris Pharma (Monmouth Junction, NJ)
- … compliance with established clinical and regulatory guidelines, operating systems and procedures in clinical trials and maintains Clinical Operations training ... immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director , Clinical Operations provides expert… more
- Eisai, Inc (Nutley, NJ)
- …maintains reporting and validation testing standards for the department, and monitors compliance with these standards.Oversee data quality management process for ... from you.JOB SUMMARY:As a member of the Data Analytics group, the Associate Director , Commercial Analytics is part of a high performing team that provides… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as… more
- Merck & Co. (Rahway, NJ)
- …management processes that govern operations, including tier, clinical siting and compliance councils. Key performance indicators range from quality and ... and product/process development, as well as oversight of the Enterprise Resource Planning systems (SAP, PAS-x) and the Data Analytics output of those areas. -The… more
- Insmed Incorporated (Bridgewater, NJ)
- …as well as reviewing and tracking CAPAs.Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices ... in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of… more
- Merck & Co. (Rahway, NJ)
- …to enable efficient and seamless access to relevant information across multiple systems and platforms.Establish data quality control processes to ensure data ... biopharma research, such as high-throughput screening devices, liquid handling systems , mass spectrometers, gene sequencing platforms, and laboratory information… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and ... support of their assigned projects. Position Description- The Principal Scientist / Director responsibilities include but are not limited to:Serve as a Regulatory… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … Quality metrics Focusing on mentoring, process excellence, and executionSustain Quality Systems to ensure no critical complaints or regulatory actionsProvide ... Position Summary The Director of Quality Operations provides direct...to oversee all quality aspects within the Quality Assurance Unit ensuring compliance with federal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key ... Quality Indicators (KQIs). Identify appropriate continuous improvement initiatives for quality and compliance related areas. Deputize for the Head of RD QA at… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality , etc. to identify, evaluate and communicate safety observations.… more
- Merck & Co. (Rahway, NJ)
- …the Design Authority.- They will ensure the smooth operation of our SAP systems with a mindset towards continuous improvement.- Their expertise in SAP System ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Insmed Incorporated (Bridgewater, NJ)
- …Patient Support Program and the reason we are seeking top talent for the role of Director , Case Management. Patients are the core of what we do here at Insmed, and ... If so, we want to hear from you! As Director of Case Management, you will be a key...while preparing for new launch products through team and systems expansions. This position reports to the Head of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Quality . Hires and develops employees within the department. Coordinates quality systems related activities among impacted individuals, departments, sites ... treatment of multiple myeloma. Legend Biotech is seeking a Director , QA Operations as part of the Quality...tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Other duties… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Practices (GEP), Good Automated Manufacturing Practices (GAMP) etc.Ability to evaluate automation systems from a compliance perspective and ensure adherence to ... Position Summary The Engineering Director is directly responsible for leading the Engineering...in the successful design, construction, and commissioning of facility systems , as well as all process and laboratory equipment.… more
- Merck & Co. (Rahway, NJ)
- …Sourcing Partners.Ensure appropriate and consistent application of SOPs, standards and quality and compliance measures.Engage with cross functional stakeholders ... statistical programming deliverables using global and TA standards and according to quality , compliance and timeliness requirements; expertise in SAS and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … compliance with SDEA requirements. Relationships This position reports to the Director , Case Review & Compliance Reporting within Patient Safety. This ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....in Patient Safety, NNI GXP Support, NNI Legal, NNI Compliance , NNI Commercial, NNI Finance, Global Business Services (GBS),… more
