- Bristol Myers Squibb (New Brunswick, NJ)
- …with regulatory inspections including pre-inspection readiness as well as regulatory inspection responses for complex compliance matters. . Assist with ... scientific discipline. . 15 plus years' experience in the pharmaceutical industry. . Thorough understanding of regulatory ...experience to ensure understanding of key business quality and compliance drivers of the Pharmaceutical Industry. .… more
- Fujifilm (College Station, TX)
- …for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT. Responsibilities will include one ... implement, and maintain the risk-based PQS sub-systems to meet all CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and… more
- J&J Family of Companies (Raynham, MA)
- …globally integrated quality management system approach balancing customer satisfaction and regulatory compliance with business objectives. + To provide ... Business, Market and Customer needs as well as in compliance with Global Regulatory Requirements. To establish...Minimum 15 years of experience in a medical device, pharmaceutical or similar regulated industry, 10 years of which… more
- SSM Health (St. Louis, MO)
- …operations, optimizing pharmaceutical usage, medication management system, regulatory compliance , purchasing, inventory management and medication safety, ... RESPONSIBILITIES + Develops and implements quality improvement activities and ensures compliance with patient care and medication practice standards within their… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management and Statistics, with at least 3 years of experience in GCP Quality/ Compliance . + Advanced knowledge of pharmaceutical development, medical affairs and ... processes and training and ensure alignment with global processes and regulatory requirements and expectations. + Drive the implementation and change management… more
- AmeriHealth Caritas (Washington, DC)
- …LOB compliance related issues and risks to senior leadership, the Regulatory Compliance Committee, Board of Directors, and other committees, as applicable. ... 439.608(b), provides oversight of all operating divisions and subsidiaries across compliance and regulatory functions, including overseeing a staff responsible… more
- WMCHealth (Valhalla, NY)
- …Summary: The 340B Program Compliance Analyst is responsible for maintaining regulatory compliance within the 340B Program across all WMCHealth entities. This ... liaison to key stakeholders, ensuring proper utilization of the 340B program and compliance with all regulatory requirements in conjunction with the 340B Program… more
- Curia (Burlington, MA)
- …departments and other key stakeholders * Support Quality Systems by driving regulatory compliance and continuous improvement activities in accordance with ... (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to...meetings * Participate in FMEA's, gap assessments and drive regulatory compliance * Provide audit support (… more
- BeOne Medicines (Pennington, NJ)
- …authoring and vendor qualification. + Development of all necessary SOPs, ensuring regulatory compliance in conjunction with being appropriate both clinical and ... **_General Description:_** Responsible for the design, implementation, and management of Compliance programs for the Hopewell, NJ site. Programs which require… more
- BeOne Medicines (Pennington, NJ)
- …cycle times, on time closure dates, and QA objectives, whilst adhering to regulatory compliance and achieving business success. Work to support both internal ... QA and Compliance SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being 'fit for purpose' operationally… more