- Bristol Myers Squibb (Devens, MA)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Director of Inspection Readiness is responsible for ensuring ... cell therapy, and medical device operations. Reporting to the Senior Director of Inspection Readiness , this individual contributor role leverages extensive… more
- Sumitomo Pharma (Boston, MA)
- …for Risk-Based Quality Management, Operational Data & Analytics, Records Management and Inspection Readiness Strategies across all clinical studies in Phase 1-4. ... or follow us on LinkedIn. **Job Overview** The **Senior Director , Clinical Operations** is a member of the Clinical...processes + Experience in clinical compliance and development of inspection readiness processes + Must have demonstrated… more
- Bristol Myers Squibb (Devens, MA)
- …manage regulatory inspections, applying principles of Quality Risk Management to ensure inspection readiness and compliance. Assist in the review and preparation ... lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Executive Director , Cell Therapy Quality Compliance, is responsible for ensuring robust… more
- Bristol Myers Squibb (Devens, MA)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director of Cell Therapy Quality Automation Services will report to the ... Executive Director of Cell Therapy Global Product Quality and serve...highest standards of cGMP compliance, product quality, and regulatory readiness as BMS automates Cell Therapy manufacturing, testing and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …activities are carried out with high quality and compliance. + Promotes inspection readiness for clinical trials and strategic supplier activities, ensuring ... are shared and applied across development programs. + Supports R&D to be inspection ready with a culture of sustainable compliance. Represents Takeda as a clinical… more
- IQVIA (Boston, MA)
- …+ Ensure real-time tracking and documentation of trial progress. + Maintain inspection - readiness throughout the trial lifecycle. + Act as the primary ... Overview:** IQVIA is seeking an experienced Associate Clinical Project Management Director /Trial Delivery Manager (TDM) to lead and coordinate global and regional… more
- Takeda Pharmaceuticals (Boston, MA)
- …for key regulatory meetings as appropriate. + Leads Clinical Operations aspects of inspection readiness activities and acts as subject matter expert during ... regulatory inspections. + Lead or participate in cross-functional strategic initiatives and process improvement. + Actively seek new ways of working more efficiently to meet the needs of clinical development. + Demonstrate advanced Takeda Leadership Behaviors… more
- Beth Israel Lahey Health (Boston, MA)
- …The Regulatory and Accreditation Program Manager reports to the Director , Regulatory Affairs. Manages the accreditation/regulatory program requirements related to ... regarding action plan and next step in preparation for or following inspection surveys, coordinates response assessment dashboards, and MOS Design, etc.), as well… more
- AMETEK.Inc (Wilmington, MA)
- …The Site Quality Manager will perform FAA Designated Manufacturing Inspection Representative (DMIR) functions, customer Designated Supplier Quality Representative ... communication, and ensure customer satisfaction. The incumbent will also ensure audit readiness and manage site 6-S initiatives. This position reports directly to… more