- AbbVie (Waltham, MA)
- …compliance program, quality documentation such as quality agreements + Perform quality assurance and GCP compliance review of various clinical study ... + Oversee vendor performance and deliverables + Perform a quality assurance review of documents and data...+ Ensure internal and external (clinical sites/vendors/CROs) adherence to GCP , GLP, and applicable regulations. + Assist in the… more
- Kelly Services (Burlington, MA)
- **Sr. Manager / Associate Director - Quality Assurance ** **Burlington, MA** **Direct Hire** **Compensation: $125k-165k base + 10-15% annual bonus** ... play a key role in expanding and shaping US-based Quality culture, including GCP and GLP compliant...as well as organize and drive performance of the quality assurance system. + Experience in a… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …and our core values by staying **True to Life.** **Job Description** The Clinical Quality Assurance Manager reports directly to the Executive Director of ... Clinical Quality Assurance and provides support to ensure...quality in adherence to agency regulations and standards, GCP , Industry guidelines, and Olympus policies and processes for… 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 ... head of 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
- Robert Half Office Team (Groton, CT)
- Description HYBRID POSITION - Candidates must reside in or near Groton, CT. As a Quality Assurance Manager , you will serve as a pivotal figure, fostering ... and clinical product development teams. Your role as a Quality Assurance Manager will be...the Pharma industry. + Strong knowledge of cGMP (not GCP ). + Proficiency in project management. + Competence in… more
- University of Rochester (Rochester, NY)
- …programs, Continuous Quality Improvement (CQI) program and the Quality Assurance Technical working group. As lead QSR Manager , work closely with CMSU ... investigational drugs and devices. **RESPONSIBILITIES:** + Direct the activities of the Quality Assurance Compliance Group within the CMSU. This group oversees… more
- Capital One (Mclean, VA)
- Center 3 (19075), United States of America, McLean, Virginia Information Assurance Third Party Management (IA TPM) Assessor The Information Assurance Third Party ... will partner with the line of business Third Party Manager and IA TPM team to evaluate the effectiveness...effectiveness of the third party's environment and deliver a quality assessment report. This enables effective risk management in… 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
- Merck (Columbus, OH)
- …effectiveness. This will include ongoing partnership with the Research & Development Division Quality Assurance (QA) and acting as the link between Clinical ... of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible for...require headquarters input. Other Responsibilities + Provides input into GCP Quality and Compliance Council regarding the… more
- Boston University (Boston, MA)
- The Human Research Protection Program (HRPP) Human Research Quality Manager will perform quality assurance monitoring and auditing on human research ... at BMC and BU Medical Campus. The Human Research Quality Manager will evaluate and verify adherence...These include both for-cause audits as well as not-for-cause ( Quality Assurance ) reviews of human and clinical… 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
- ThermoFisher Scientific (Wilmington, NC)
- …and prioritize complex demands/workload + individuals with prior experience in Clinical Quality Assurance /Compliance - GCP audit, inspection, consultancy ... internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or… more
- PCI Pharma Services (Rockford, IL)
- …coordinate and facilitate the + customer Quarterly Business Review's. + Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality ... Coordinator(s) while partnering with the Sr. Clinical Project Manager to ensure that we deliver a quality...Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. + Attendance to work is… more
- PCI Pharma Services (Rockford, IL)
- …remaining within cGMP guidelines and PCI procedures and policies. + Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality ... Coordinator(s) while partnering with the Sr. Clinical Project Manager to ensure that we deliver a quality...Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. + Attendance at work is… more
- PCI Pharma Services (Philadelphia, PA)
- …Assist with creating and/or reviewing batch records to support the business. Primary Quality Assurance contact for assigned customer accounts. + Assist as ... and shape the future of PCI. **SUMMARY** The Associate Quality Account Manager I is responsible for...Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. + Attendance to work is… more
- J&J Family of Companies (Annapolis, MD)
- …closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified ... Senior Site Manager , Oncology - Southeastern US - 2406181831W **Description**...protocol, company Standard Operating Procedures (SOP), Good Clinical Practice ( GCP ), and applicable regulations and guidelines from study start-up… more
- Johns Hopkins University (Baltimore, MD)
- …Keep enrollments on track with established performance expectations. + Provide support for quality assurance monitors in all facets of work related to ... delivered on-time and within the budget, adhere to high quality standards, and benefit the investigative teams by ensuring...to trial execution. + Advanced knowledge and experience with GCP /ICH and local regulations. + Experience in web-based data… more
- Boston University (Boston, MA)
- …issues, DSMP development, planning and submitting protocols to the IRB. + Working with the Quality Assurance team to understand issues that come up in QA Reviews ... to best practices. The Clinical Research Resources Office (CRRO) Regulatory Education Manager will manage two important aspects of the HRPP: the Research… more
- Ford Motor Company (Dearborn, MI)
- …at required pace. 10. Drive adoption of standardized architecture, design and quality assurance approaches across all workstreams and ensure solutions adheres ... from New North America Lending platforms into Data Factory ( GCP BQ), and build upon the existing analytical data,...teams and oversee adherence to engineering patterns and data quality and compliance standards, across all data factory workstreams.… more
- Cook Medical (Pittsburgh, PA)
- …with management, especially the Computer System Applications, Information Technology, and Quality Assurance departments, to establish the philosophy for ... we invite you to apply. The Computer System Validation Manager at Cook MyoSite, Inc. manages validation staffing and...IQs, OQs, PQs, VSs, etc.) as needed.* Work with Quality Assurance to ensure alignment for an… more