- Danaher Corporation (Boston, MA)
- …guiding regulatory activities, this role ensures smooth global commercialization and compliance , driving innovation and excellence in the Biopharma sector. This ... execution for external partnerships and product lifecycle management, ensuring compliance with global requirements and state-of-the-art standards. + Maintain… more
- Dana-Farber Cancer Institute (Boston, MA)
- …clinical and operational outcomes. + Familiarity with healthcare regulations and compliance standards relevant to cel therapies including, FDA guidelines, ... and implementation of new IT architecture, ensuring scalability, security, and compliance with healthcare regulations. + Manage relationships with key stakeholders,… more
- Integra LifeSciences (Mansfield, MA)
- …apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times. + Ensures that in process quality checks are completed ... accordance with all requirements for manufacturing medical devices (eg FDA QSR, ISO 9000, ISO 13485). + Completes required...and maintains the highest levels of professionalism, ethics and compliance at all times. + Partners with engineering team… more
- ThermoFisher Scientific (Plainville, MA)
- …& Analytics to the cGMP QC testing laboratory. The manager ensures cGMP compliance , operates within budgets, and supervises bioanalytical lab staff directly and QC ... Viral, Cell, and Tissue Culture operations and contract testing. Ensure compliance , accuracy, and timeliness of testing processes. Lead the introduction of… more
- Fujifilm (Boston, MA)
- …mapping for project and or post go-live support cases in compliance with the company's quality procedures. **Company Overview** At FUJIFILM Healthcare ... customization, and electronic delivery of technical clinical tools and supplements. + Compliance with respect to all applicable requirements of the company's quality… more
- Rhythm Pharmaceuticals (Boston, MA)
- …the effective management and timely execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will provide ... timelines + Ensure effective and timely execution of regulatory filings in compliance with relevant regulatory standards and commitments + Lead the planning and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …effectiveness and implement continuous improvement **Clinical Quality Assurance & Compliance :** + Implement quality management systems for clinical activities ... control processes and risk management methodologies + Thorough understanding of FDA , EMA, and international regulations for medical devices and combination products… more
- Amentum (Boston, MA)
- …+ Ensures that all program activities and operations are carried out in compliance with local, state and federal regulations and laws governing business operations. ... education. + Strong understanding of cGMP operations, regulatory requirements (like FDA , EMA, ICH guidelines) + Strong analytical and problem-solving skills,… more
- Sanofi Group (Cambridge, MA)
- …high-touch role, you will assist patients and caregivers with accessing Sanofi's FDA -approved T1D therapy, facilitating insurance approvals for both the product and ... Provide caseload coverage outside of assigned territory as needed + Ensure compliance with all Sanofi policies **About You** **Qualifications:** + Bachelor's degree… more
- United Therapeutics (Boston, MA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... respond to those needs + Facilitate a culture of accountability and compliance through ongoing cadence discussions with field leaders and internal partners to… more