- Sanofi Group (Swiftwater, PA)
- …for ensuring all Computerized Systems Validation (CSV) lifecycle activities meet Sanofi's quality requirements and fulfil regulatory expectations. + Design and ... are released for GMP use. + Provide support during regulatory inspections and site audits as quality ...and soft skills: + Sound knowledge and understanding of regulatory (including FDA 21 CFR Part 11,… more
- Community Health Systems (Dunmore, PA)
- …treatment of breast diseases. This role requires advanced technical skills, adherence to FDA /MQSA, ACR, and state regulatory standards, and a strong commitment ... positioning, imaging techniques, and radiation protection. + Strong understanding of FDA /MQSA, ACR, and state regulatory compliance requirements. + Ability… more
- Globus Medical, Inc. (Audubon, PA)
- …ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Designing and developing ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...and market plans + Assisting in the writing of regulatory applications to the FDA and other… more
- Insight Global (Upper Gwynedd, PA)
- …administration, SQL, Python, web and API development with deep understanding of regulatory requirements (eg, FDA , EMA, GxP) and data governance standards. ... bioinformaticians, laboratory scientists, and IT professionals to deliver compliant, high- quality data solutions that support critical bioanalytical workflow. They… more
- System One (Pittsburgh, PA)
- …accessible manner to stakeholders. + Ensure all statistical work complies with relevant regulatory guidelines (eg, FDA , EMA) and Good Clinical Practices (GCP). + ... and analysis. + Ensure data integrity by monitoring data quality and completeness during the trial. Work closely with...Strong knowledge of clinical trial design, statistical methods, and regulatory requirements ( FDA , EMA). + Experience with… more
- MTF (Olyphant, PA)
- …orders, and delays to final tissue production. 5. Evaluate and adhere to quality , compliance, and regulatory requirements for packaging and documenting time ... of finished tissue packaging materials for shipment to contract sterilizer. Maintain MTF's quality assurance standards and compliance with ISO, AATB, TGA and FDA … more
- Sanofi Group (Swiftwater, PA)
- …sponsor/monitor inspectorate activities. As such, they may interact with representatives of Regulatory Agencies ( FDA , MHRA, PMDA, NMPA, ANSM, EMA, etc.). ... assessing GCP Compliance in clinical related activities and supporting the Quality Management System to minimize risk. Responsible for the preparation, initiation,… more
- University of Pennsylvania (Philadelphia, PA)
- …of study activities, including subject recruitment, data collection, regulatory documentation, and communication with internal and external collaborators. ... research nurses, and staff at Penn and partner institutions to ensure high- quality execution of research protocols. Attention to patient safety, data integrity, and… more
- Penn Medicine (Philadelphia, PA)
- …direction for collection, evaluation, and dissemination of National Database for Nursing Quality Indicators (NDNQI) and other Magnet related data. As it relates to ... excellence, while ensuring inter-professional collaboration to support the delivery of high- quality clinical care. Also aligns the Department of Nursing work with… more
- Philips (New Kensington, PA)
- …teams, ensuring alignment with strategic business objectives. + Coordinate with Quality , Regulatory , R&D, Operations, and Marketing teams to meet ... goals related to quality , timelines, budgets, and resources. + Navigate matrixed organizations...resolution through robust tracking and reporting mechanisms. + Ensure regulatory compliance with FDA design controls and… more