- Ascendis Pharma (Palo Alto, CA)
- …the business, from drug development to marketing. This position is based in the US. The Director , GCP & GVP Quality is responsible for the management of ... risk-based Quality Strategy, and maintenance of vendor qualification, global GCP and GVP processes, standards, and compliance monitoring systems. Responsible for… more
- HistoWiz (Long Island City, NY)
- …services into GLP to support our customers' growing histology needs. Who are you? The Senior Manager/ Director of Quality is responsible for overseeing the ... and enabling global collaboration. We are looking for a Quality Assurance Specialist interested in joining our mission and...experience + In-depth knowledge and experience with GLP and/or GCP regulations and industry standards (EPA, OECD, FDA, EU… more
- e CancerCare (Fresno, CA)
- Purpose: The Director , Clinical Trials & Research, for CCARE Physicians, PC, is responsible and accountable for the daily operations and management of staff, of the ... compliance with all regulatory requirements and standards of good practice ( GCP ) related to the conduct of clinical research. Responsibilities/Essential Functions… more
- Staples (Framingham, MA)
- Join the Data Solutions Engineering as a Director of Datawarehouse & Analytics and be part of Staples exciting journey to redefine customer experience and deliver ... Learning (ML/AI). We are seeking an accomplished and forward-thinking director with a specialized focus on ML/AI, Data Architecture,...of our North American Delivery (NAD) organization. As the senior leader of a team of highly skilled data… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... with BeiGene functional leadership (including but not limited to clinical Operation, Quality , Regulatory, CMC, and GRDS) to ensure alignment of organizations and… more
- WCG Clinical (Princeton, NJ)
- Senior Director Project Management (Remote) **General...to develop new products and therapies to improve the quality of human health. It is our role to ... $118,170 to $197,500 **GPS LEVEL:** M4 **JOB SUMMARY:** The Senior Director , Project Management will lead the...in a regulated environment and knowledge of clinical research ( GCP , CFR Part 11, basic regulatory requirements) required. +… more
- Editas Medicine (Cambridge, MA)
- …more equitable future. Position Summary Reporting to the VP of Biometrics, the Director /Sr. Director , Clinical Data Management is responsible for all clinical ... activities related to the effective planning and timely delivery of complete, high quality and reliable clinical trial data. This person is expected to be a… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …is true to the best of my knowledge. **Job Description** **Job Description for Senior Medical Director , Clinical Science, Marketed Products Development** As the ... Senior Medical Director Marketed Products (SMDMP) you will report to the...stakeholders involved in the support of assigned products, including Quality , Global Manufacturing and Supply, Medical Affairs (Global and… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The role of Senior Clinical Program Leader (CPL) - Retinal health, assumes full medico-scientific and strategic leadership of clinical programs with ... accelerate clinical development and achieve regulatory approvals and reimbursable medicines. Senior CPL provides continuous medical benefit and risk oversight for… more
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Director will be the clinical lead to progress multiple early ... training and mentoring of Early Clinical Development Physicians + Champions a quality -focused mindset and ensures adherence to GCP and compliance obligations… more
- CSL Behring (King Of Prussia, PA)
- …biotherapies used to treat serious and often rare conditions. Could you be our next Senior Director of Clinical Research and Development? This is a hybrid role ... and matrix team members. + You will be a senior medical representative on the clinical development and product...efficient, and execution of assigned programs, ensuring the highest quality and full compliance of all outputs. + Accountable… more
- Merck (Columbus, OH)
- …level sites that require headquarters input. Other Responsibilities + Provides input into GCP Quality and Compliance Council regarding the Quality Management ... new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific… more
- BeiGene (Emeryville, CA)
- …+ Accountable for regional study or portfolio delivery with appropriate inspection readiness quality , within agreed timelines and budget + May act as regional lead ... Functions of the job:** **Regional Leadership** + Influences improved standards of quality and efficiency for the region, promoting subject matter, disease area, or… more
- GRAIL (Menlo Park, CA)
- …Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com . The Sr. Director , Medical Safety will lead the development and implementation of a robust ... post-market surveillance phases. This leadership role will be within the Quality , Regulatory and Clinical Compliance organization, and will collaborate with… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of Sr Director - Medicines Quality Organization (MQO) is for the design, implementation, ... and manufacturing capabilities and sites as well as corporate quality teams. This Sr Director will operate...and ensure operation in a manner such that all GCP /GVP activities are followed. + The Sr Director… more
- University of Rochester (Rochester, NY)
- …and Technology: + Manage, direct and oversee all aspects of internal and external quality and compliance systems relating to routine daily operations as well as the ... establishment of new quality standards and compliance systems supporting projects with territories...States and North America. Working closely with the Executive Director of Strategic Initiatives, continually modify, as necessary, current… more
- Bristol Myers Squibb (Princeton, NJ)
- …CSRs, regulatory reports, briefing books and submission documents + Champions a quality -focused mindset and ensures adherence to GCP and compliance obligations ... target label indications and are designed to meet regulatory, quality , medical, and access goals + Serves as a...of multiple clinical trials (eg significant experience as a senior clinical leader), and exhibits all of the following… more
- Bristol Myers Squibb (Cambridge, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Clinical Scientist reports through the Clinical Science function which provides ... adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing) + Site-facing activities such as… more
- Gilead Sciences, Inc. (Foster City, CA)
- …risk minimization activities, and aggregate safety reports are performed in a timely and quality manner. You will also provide input on behalf of PS TA into ... practices, policies, processes, and any regulatory or other requirements. + Advises senior management on the PS TA strategy and pathway to achieve therapeutic… more
- Southern Glazer's Wine and Spirits (Miramar, FL)
- …collaborate with cross-functional teams, and ensure the delivery of high- quality , secure, and performant platforms. **Primary Responsibilities** + Envision a ... respective environments. + Partner with QA teams to ensure quality and stability of built & packaged platform services...in Cloud such as Microsoft Azure (preferable), AWS or GCP * Experience in working with Docker / Containerization,… more