- Sanofi Group (Framingham, MA)
- **Job Title:** Compliance Head - US FDA **Location** : Framingham, MA, Morristown, NJ **Job Title:** Compliance Head - US FDA **Location** ... thought was possible. Ready to get started? **Main Responsibilities:** . **Ensure US FDA GMP Inspection Readiness, Inspection Activities, Inspection Follow-Up**… more
- Sanofi Group (Framingham, MA)
- …and Regulatory Inspections. + Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products ... + Direct experience preparing for and supporting Regulatory Inspections from Regulators (eg, US FDA , ANSM, PMDA, NMPA, EMA, MHRA, etc.) + Action oriented,… more
- AbbVie (Worcester, MA)
- …neuroscience, and eye care. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and ... member of the quality leadership team and reports directly to the Site Head of Quality. This role is responsible for providing strategic leadership, appropriate… more
- Fujifilm (Providence, RI)
- …+ Comply with all applicable US Food and Drug Administration ( US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagnostic...electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world… more
- Sanofi Group (Framingham, MA)
- …the following activities: + Manage the quality technical operations as a SME and compliance of the CMOs & CTLs to ensure timely disposition of clinical product. + ... GMU platform leadership team providing Quality direction to the head of GMU operations. + Participate in regulatory inspections...Competencies:** + Strong knowledge of cGMP / ICH / FDA / EMA regulation; strong background with specific regulations… more