- Takeda Pharmaceuticals (Lexington, MA)
- …effectiveness and implement continuous improvement **Clinical Quality Assurance & Compliance :** + Implement quality management systems for clinical activities ... + Minimum 5 years of combination product, medical device, or pharmaceutical industry experience + Experience with both medical devices, drug-device combination… more
- Takeda Pharmaceuticals (Boston, MA)
- …risks and regulatory requirements, such as the federal Anti-Kickback Statute, OIG Compliance Program Guidance, FDA legislation, FCPA, UK Bribery Act, etc., ... * Lead and conduct audits of Takeda's Non-GxP financial, operational, and compliance processes to evaluate Takeda's control environment within the Americas region… more
- Rhythm Pharmaceuticals (Boston, MA)
- …or related field. + 5+ years of relevant experience in the pharmaceutical industry, with established Quality and Compliance knowledge in manufacturing ... office to play a key role in ensuring quality and regulation-based compliance during the manufacture and distribution of Rhythm clinical and commercial products.… more
- NTT DATA North America (Canton, MA)
- …ABAP and BTP). Ensure adherence to SAP best practices, governance frameworks, and compliance standards. Ensure alignment with GxP, FDA , EMA, and other regulatory ... leader who understands the regulatory, operational, and technological nuances of pharmaceutical , biotech, or medical device environments and can deliver SAP… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …a highly skilled, self-motivated **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences ... will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory standards such as 21 CFR Part… more
- BioLife Plasma Services (Boston, MA)
- …management. Gain exposure to real-world challenges such as audit processes, compliance requirements, and team performance management. + **Production Environment & ... service by assisting with production tasks while maintaining strict regulatory compliance and safety standards. + **Develop Leadership and Employee Relations… more
- Integra LifeSciences (Braintree, MA)
- …+ Ensure compliance with safety, environmental, and regulatory standards (eg, FDA , ISO). + Maintain accurate records of refrigerant usage and system performance. ... regulated industries and a strong understanding of refrigeration systems, compliance standards, and preventive maintenance practices. **Key Responsibilities:** +… more
- Charles River Laboratories (Boston, MA)
- …that the health and welfare of laboratory animals are maintained in compliance with local, state, federal and institutional guidelines and regulations. Responsible ... and implementation of site-specific standard operating procedures (SOP's), in compliance with all state, federal and industry requirements. Oversee adherence… more
- Takeda Pharmaceuticals (Boston, MA)
- …Director, Clinical Trial Configuration. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led ... analysis plans, CRFs, study reports) and processes. + Strategic knowledge of FDA and ICH regulations and industry standards and quality control principles. +… more
- Charles River Laboratories (Wilmington, MA)
- …change orders * Partner with the Revenue Recognition COE to ensure compliance (ASC 606) and alignment with financial policies * Monitor project-level profitability ... tracking, margin analysis, and billing processes * Support audit, SOX, and compliance requirements as needed * Identify and implement improvements in systems and… more