- 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
- Kelly Services (Burlington, MA)
- **Sr. Manager/ Associate Director - Quality Assurance ** **Burlington, MA** **Direct Hire** **Compensation: $125k-165k base + 10-15% annual bonus** ... function. This individual will report to the Sr. Director of Global GCP /GLP compliance and while...as well as organize and drive performance of the quality assurance system. + Experience in a… more
- University of Rochester (Rochester, NY)
- …ensure compliance with project and regulatory standards + Administration of all internal Quality Assurance ( QA ) systems including investigational drug and ... Continuous Quality Improvement (CQI) program and the Quality Assurance Technical working group. As lead...and experience preferred. + Strong working knowledge of International GCP /GMPs, compliance auditing, QA experience, and … more
- Frontier Medicines (Boston, MA)
- Join us as the Senior Manager/Associate Director of Quality Assurance at Frontier, where precision meets purpose. In this pivotal role, you'll oversee GCP ... RA/ QA as we navigate the complexities of quality assurance with precision and purpose. Requirements...not limited to: US CFR, EU CTD, and ICH GCP + Familiarity with electronic document management systems and… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …values by staying **True to Life.** **Job Description** The Clinical Quality Assurance Manager reports directly to the Executive Director of Clinical ... Engineering) + Minimum of 7 years of experience working in clinical quality assurance /operations roles (medical device industry strongly preferred). + Minimum… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …approvals. Lead in a proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for all GxP matters for ... Program Head and the Global Program Team. Provide operational QA leadership for the respective GPTs, including Quality...Quality professionals at strategic project team and at GCP strategic discussions. + Support the Head of RD… more
- Novo Nordisk (Lexington, MA)
- …inspection host & back-room lead + Experience with clinical quality assurance , clinical trial management/monitoring or GCP Audits + Organizational and ... for patients. Do you dream of using your solid GCP knowledge, process optimisation skills and quality ...of experience in clinical research drug development and/or Clinical Quality Assurance ; 6 years with a Masters… more
- Pfizer (New York, NY)
- …Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Quality Assurance and Control ... not limited to quality investigations, external stakeholder engagement, and Quality Management System support. The Director , Inspection Management Lead… more
- Merck (Columbus, OH)
- …business effectiveness. This will include ongoing partnership with the Research & Development Division Quality Assurance ( QA ) and acting as the link between ... that require headquarters input. Other Responsibilities + Provides input into GCP Quality and Compliance Council regarding the Quality Management System… more
- HistoWiz (Long Island City, NY)
- …by accelerating histopathology and enabling global collaboration. We are looking for a Quality Assurance Specialist interested in joining our mission and serving ... customers' growing histology needs. Who are you? The Senior Manager/ Director of Quality is responsible for overseeing...field + At least 5 years of experience in Quality Assurance working at a CRO, pharma,… more
- Pfizer (South San Francisco, CA)
- … issues management and general GCP guidance. **ROLE RESPONSIBILITIES** Level 1 GCP Quality : + IQMP (Integrated Quality Management Plan) Development and ... accountability to clinical teams in their tumor type(s) for GCP advice and guidance. + Strategically utilize quality...and operational quality management disciplines such as, quality and compliance assessments, quality assurance… more
- Lilly (Indianapolis, IN)
- …support the evolving cell and gene therapy landscape. This role is responsible for quality assurance , quality risk assessment and mitigation, continual ... Clinical Design, Delivery and Analytics (CDDA), Manufacturing, MQO, Global Quality Assurance Auditing & Compliance, Legal, and...and ensure operation in a manner such that all GCP /GVP activities are followed. + The Sr Director… more
- GRAIL (Durham, NC)
- …Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com . Grail's Clinical Quality Assurance (CQA) department is seeking a compliance expert to ... Director will work cross-functionally to manage Grail's Clinical Quality Management System; conduct gap assessment and audit of...CFR Part 812 and Part 11]. + Experience managing GCP quality processes such as managing … 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
- University of Rochester (Rochester, NY)
- …of approximately 15 team members, with two Directors ( Director Operations and Director Quality Assurance ) and the clinical trials it supports in ... organizations 2. Oversee all aspects of operations, including operations, quality assurance , facilities, finance and administration, project prioritization,… more
- Aspen Dental (Chicago, IL)
- …and resources to grow their practices, and an unwavering commitment to delivering high- quality consumer healthcare experiences at scale. TAG has reached the size to ... created an opportunity to join our team as a Director of Software Engineering. As a Director ,...systems by developing new software and services using cloud-native GCP technologies, using Microsoft .NET (Core/6) stack on Kubernetes.… 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
- Lundbeck (Deerfield, IL)
- …with cross-functional teams, including clinical operations, regulatory affairs, legal and quality assurance , to drive process improvements and implement best ... Associate Director Medical Communications - Remote Opportunity Requisition ID:...creation and for ensuring the delivery of accurate, high quality medical review and medical information in an efficient… more
- Taiho Oncology (Pleasanton, CA)
- …guidance and support to Clinical, Medical and Safety teams. + Together with Quality Assurance , manage regulatory compliance for sponsor activities for drug ... Sr. Director , Regulatory Affairs Strategy Pleasanton, CA, USA Req...directs the project/product teams' regulatory activities to ensure high quality , regulatory integrity, and completeness of all projects. The… more
- ICON Clinical Research (Salt Lake City, UT)
- …clinical research to inform study design and strategy. **Regulatory Compliance and Quality Assurance ** + Ensure compliance with regulatory requirements and ... an industry. **Position Overview** We are seeking a dynamic and experienced Medical Director to lead our team of physician principal investigators in the conduct of… more