- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and clinical project management competencies within Clinical OperationsWork in collaboration with Quality Management and Quality Assurance to develop and ... research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ensure… more
- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond to ... is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to the… more
- University of Rochester (Rochester, NY)
- …and management programs, Continuous Quality Improvement (CQI) program and the Quality Assurance Technical working group. As lead QSR Manager, work closely ... investigational drugs and devices. **RESPONSIBILITIES:** + Direct the activities of the Quality Assurance Compliance Group within the CMSU. This group oversees… 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
- 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
- Amgen (Washington, DC)
- …for supporting the implementation of an end to end, proactive and risk-based Quality Assurance strategy for IVD, and Precision Medicine, including third-party ... for a career you can be proud of. **Associate Director , In-Vitro Diagnostics / Precision Medicine Quality **...and communicate impact to the business. + Provides risk-based quality assurance and oversight for IVD/ Precision… more
- CSL Behring (King Of Prussia, PA)
- As Associate Director , Senior Quality Auditor, you will...across all GxP sites and teams, local and global Quality Assurance and Quality Control ... experience working at an Inspectorate, preferably USFDA. . Direct experience executing Quality Assurance / Quality systems activities required. . Experience… 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
- GRAIL (Menlo Park, CA)
- …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
- Amicus Therapeutics (Princeton, NJ)
- …* Minimum of either (8) years' experience in the pharmaceutical/CRO industries, within Assurance Function. This includes GCP /GLP and Part 11 auditing experience ... Director , GXP Audits and Inspections Location Princeton, NJ...patient-dedicated biotechnology company focused on discovering, developing, and delivering high- quality medicines for people living with rare metabolic diseases.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …clinical project management competencies within Clinical Operations + Work in collaboration with Quality Management and Quality Assurance to develop and ... areas centered around rare diseases and immune disorders. **Summary** The Senior Director of Clinical Operations will manage clinical operations staff to ensure the… more
- Boehringer Ingelheim (Ridgefield, CT)
- …at third parties including service providers and PSPV license partners. The purpose of our Quality Assurance audits is to assess the audited area to ensure that ... **Description** As a Global QM Auditor in our Corporate Department Quality Medicine (QM), you will perform audits covering functional areas within Corporate Division… 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
- 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
- SMBC (Sacramento, CA)
- …banking. **SUMMARY:** SMBC MANUBANK is seeking an experienced Digital Banking Audit Director to work with the Internal Audit Department. The Audit Director ... This position will report to the MB Audit Executive Director , Internal Audit Team Lead who in turn reports...responsibilities appropriately. + Manage audit teams to execute high quality reviews within a prescribed timeframe. + Determine scope… more
- Taiho Oncology (Princeton, NJ)
- …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 Princeton, NJ, USA Req...directs the project/product teams' regulatory activities to ensure high quality , regulatory integrity, and completeness of all projects. The… more
- BeiGene (Emeryville, CA)
- …effective communication and collaboration with functional area peers including Drug Safety, Quality Assurance and Regulatory Affairs, as well as thought leaders ... The Associate Director (AD) Clinical Study Management leads both indirect...expansion as an organization. **Essential Functions of the job:** ** Quality ** + Supports the development of department initiatives, including… more
- Sprinklr (GA)
- …instructional designers. + Foster collaboration to create engaging and effective lab content. ** Quality Assurance ** : + Implement quality control measures to ... through **The Sprinklr Way (http://get.sprinklr.com/hubfs/SprinklrWay.pdf)** . **Job Description** As the ** Director of Virtual Labs** at **Sprinklr** , you will be… more
- Lilly (IN)
- …needs to ensure optimized supply plan. + Partner with key stakeholders (including Quality Assurance and Regulatory Affairs) to ensure supplies are packaged, ... Stamford, Connecticut; and Madrid, Spain. In this leadership role, the Senior Director , Clinical Supply will oversee all aspects of clinical supply management and… more
- Bristol Myers Squibb (Madison, NJ)
- …+ Ensures high quality and timely delivery of protocols and data; implements quality assurance plans + Maintains an advanced understanding of the status of ... Responsibilities** + Leads a team or complex scope of work to ensure high quality delivery of innovative protocols and data packages for CSRs and Regulatory Filings… more