- GE HealthCare (IN)
- …adaptation of quality assurance processes + Overall, the role of a GCP Quality Assurance Oversight Team Leader is critical for maintaining the ... **Job Description Summary** The Global Compliance Quality Assurance R&D / GCP...related functions. This role reports directly to the Senior Director Global Compliance and Quality Systems Pharmaceutical… 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
- 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
- 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
- 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
- Walgreens (Deerfield, IL)
- …and maintenance of the Quality Management System (QMS) under oversight of the Sr. Director of Quality Assurance . The Quality Assurance function ... critical or major findings or trends to the Sr. Director of Quality Assurance . +...clinical trials models. + Exceptional working knowledge of ICH GCP , US CFR, and HIPAA regulations. + Experience working… 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
- BeiGene (San Mateo, CA)
- …responsible for implementing and maintaining a balanced, proactive, and phase appropriate approach to GCP , GVP and GLP Quality Assurance . This position will ... **General Description:** The Director GCP /GLP/GVP Systems & Data Integrity,...and operations and develop improvement strategies. + Assisting R&D Quality GCP , GVP and GLP Inspection Management… 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
- Pfizer (New York, NY)
- …system strategies to assure high quality , effective, optimized and efficient Regulatory Quality Assurance (RQA) programs, and effective Quality & Risk ... **ROLE SUMMARY** The Director , Quality Digital Team Lead is...E-Verify employer. This position requires permanent work authorization in the United States. Quality Assurance and Control… more
- GRAIL (Durham, NC)
- Grail's Clinical Quality Assurance (CQA) department is seeking a compliance expert to support compliant conduct of Grail's clinical studies and to support ... 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
- 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
- Actalent (Jersey City, NJ)
- …of Clinical QA to join their group. Main Responsibilities + Lead and provide overall quality assurance strategies + Define and execute overall quality ... of pharmaceutical or biotech industry experience + Must have 5+ years of hands-on quality assurance lead experience + Experience in leading internal and vendor… 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
- Ascendis Pharma (Palo Alto, CA)
- …provide appropriate representation during PV related regulatory inspections or internal quality assurance /corporate compliance audits + Work collaboratively with ... The Associate Director Global PV Operations reports directly to the..., Medical Safety Science-Oncology by contributing to the Vendor Quality Agreements + Accountable for maintaining oversight over Source… more
- Merck (Columbus, OH)
- …closely with the Quality Assurance group and the Good Clinical Practice Quality and Compliance Council ( GCP QCC). + Represent GCTO and the country on ... in our headquarters. Additionally, there are important interactions with, inter alia, Quality Assurance , Finance, Regulatory, Clinical Supplies and legal in a… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …+ Collaborate with team members, vendors, Global development vendor relationship managers and Quality to align on quality assurance /controls and financial ... We are looking for a Director Global Procurement-R&D- Inspection Readiness to be responsible...non-compliance risks across clinical trial vendors and working alongside quality assurance for regular audits and evaluations… 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
- Academy Sports + Outdoors (Katy, TX)
- …with relevant teams to ensure timely recovery during disruptions. Service Delivery and Quality Assurance : + The Director is responsible for ensuring ... environment that values hard work, commitment, and growth . Job Description: As a Director of Infrastructure and Operations, you will play a pivotal role in shaping… more