- 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
- West Pharmaceutical Services (Exton, PA)
- …and utilize specialized expertise in SAP Production Planning to collaborate with Quality and Operations to define detailed User Stories for Digital and ... within the ERP Services Delivery model, West policies, and procedures as well as regulatory requirements including but not limited to Sarbanes-Oxley and FDA GMP.… more
- Geisinger (Danville, PA)
- …improvements for dosimetry or image quality . + Supports inspections/audits from regulatory /recommending bodies including TJC, PA DEP, FDA , ACR, and DOH. + ... Physics Department. Job Duties + Meets and maintains the ACR and Mammography Quality Standards Act (MQSA) requirements for being listed as a qualified medical… more
- Penn Medicine (Philadelphia, PA)
- …leadership and direction in regards to all administrative, financial, regulatory , quality , human resources, patient/employee satisfaction, and clinical ... all areas of accountability are compliant with all federal, state and local regulatory standards and requirements, including DOH, TJC, FDA , HIPAA, HCFA, DPW,… more
- Penn Medicine (Berwyn, PA)
- …supervision and direction in regards to all administrative, financial, regulatory , quality , human resources, patient/employee satisfaction, and clinical ... all areas of accountability are compliant with all federal, state and local regulatory standards and requirements, including DOH, TJC, FDA , HIPAA, HCFA, DPW,… more
- University of Pennsylvania (Philadelphia, PA)
- …comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator ... research investigators, Research Team Leaders, our clinical research nurse(s), and regulatory coordinator. The ACC received an exceptional rating from the National… more
- Cardinal Health (Harrisburg, PA)
- …research, industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and ... to update manufacturer knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct secondary research (eg,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …across Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health ... + Various standards (GCP, ISO 13485, ISO 14971) + Regulatory filings ( FDA IDE, 510K, EU-MDR CERs,...cross functional teams and contribute to the resolution of quality -related issues in a timely and effective manner. +… more
- UPMC (Pittsburgh, PA)
- …No holidays or weekends are required! The QA Associate will coordinate the quality management, safety, and regulatory activities for the Cellular Processing ... you will act as the liaison between nursing, the quality departments, and the regulatory departments of...Drug Master Files that will be submitted to the FDA . Assist to create and maintain the Laboratory Disaster… more
- Sanofi Group (Swiftwater, PA)
- …of a safe and efficacious product. + Utilizes +QDCI boards for Safety issues ** Quality :** + Regulatory audit understanding and awareness. Point of contact for ... goals and priorities. Assures operations are conducted in compliance with regulatory authorities. Assures operations are conducted in compliance with cGMPs, CBER,… more