- Catalent (Harman, WV)
- …the site metrics, management review, and building a Patient First culture at the site . The Head of Quality -Maryland is responsible for Quality , ... Position SummaryThe Head of Quality -Maryland is responsible for...contact (with both customers and regulatory agencies) for the site Quality Unit. Develop and implement … more
- Merck & Co. (Millsboro, DE)
- …and program reviews is required.PurposeThe Associate Director/Attending Veterinarian will report to the Site Quality Head /Director of Quality . The ... (IACUC), and facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination with other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall strategic oversight of study management ... for ensuring the clinical trial portfolio and submissions are delivered to time, quality , and cost. The teams reporting into this role must ensure robust strategic… more
- Merck & Co. (Rahway, NJ)
- …General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head 's primary objectives will be to:Develop and create a new Center of ... design and monitoring of clinical programs and studies, producing high- quality clinical documents and presentations.Collaborate with functional area leaders within… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …supporting all aspects of the Quality unit. You will report to the site Quality Head of QA/QC and Regulatory.Experience Fujifilm Diosynth Biotechnologies ... the responsibility of driving operational excellence and continuous improvements initiatives together with the site and Global Quality functions. The role covers… more
- Insmed Incorporated (Bridgewater, NJ)
- … Quality Control and Quality Assurance.Commercial drug manufacturing site QA head experience preferredAbility to drive functional, technical, and ... York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …QA and will have the primary responsibility to collaborate with, and support the head of Global QA strategy and operations. In this position, the incumbent will take ... of N-3 leaders directly reporting to the VP of Quality , and in close collaboration with the QA Training...under the direction of the Global Strategy and Operations Head , to draft presentation for VP of QA, assess… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DSI QA Functional activities and Global QA activities. This position performs support tasks Head Global R&D PV QA and Global R&D PV QA Leadership members as well ... as Head Global Strategy & Operations (RDPVMA QA). This position...accurate and reflects on going activities. Regularly check the site for accuracy, up to date information, and links… more
- Daiichi Sankyo, Inc. (Munich, ND)
- …the sites. Responsible for coordination across functional areas addressing time, cost and quality of deliverables.Works with the OEDC Head to select sites that ... for content management.Identifies trends, issues and risks across the network sites.Utilizes site performance and quality data to optimize prioritization of… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.Our ... to produce safe, effective, innovative medicine.Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for budget/finance aspects, for… more
- Merck & Co. (Rahway, NJ)
- …high rigor in CMC regulatory strategy as well as delivery of high- quality CMC submissions for products which could span traditional solid-oral small molecules ... regulatory environment with potential strategic impact working closely with the Head of CMC Regulatory Policy.Performs risk assessments for determination of… more
- Merck & Co. (North Wales, PA)
- …in clinical trials, ensuring timelines and deliverables are met and of high quality . The CPS also leads operational and scientific initiatives to improve the ... aspects of our development programs. This position will work closely with the Head of Clinical Imaging and Pathology, Pathology Leads, and other Clinical Pathology… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that will translate into capacity and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... Responsible for upholding and promoting the Novo Nordisk (NN) Quality Management System (QMS) as the framework that enables...reports to the Associate Director of GXP Oversight and/or Head of GXP Support. Multiple internal relationships exist with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operational planning, start-up, conduct, reporting, and close out) including timeline, quality , and budget management Drives and leads the successful execution of ... of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical… more
- Novo Nordisk Inc. (Boulder, CO)
- About the Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Aequor (Thousand Oaks, CA)
- …will work in a dynamic production environment at the Thousand Oaks Site supporting development, clinical, and launch activities. Under general supervision, employee ... clean room gowning, hairnet and gloves when performing all work Initiating quality reports Drafting and revising documents (SOPs, MPs) Identifying, recommending, and… more
- Insmed Incorporated (Bridgewater, NJ)
- …new launch products through team and systems expansions. This position reports to the Head of Patient Access and will be located at our Bridgewater, NJ headquarters ... and regulations Auding and monitoring case manager calls and reports for quality and insights and coach accordingly QualificationsMinimum 10 years of Patient… more
- FUJIFILM Holdings America Corporation (College Station, TX)
- …a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.The ... clients and the Company's vision/mission (strategy and compliance). Reports to Head of Program ManagementWork Location College Station, TX Travel As neededPrimary… more
- Spectraforce Technologies Inc (Summit, NJ)
- …format according to proper GDPs. Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements. Works in a team ... shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. Required Competencies: Knowledge/… more
