- Parexel (Boston, MA)
- …approach. The CQOM will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up ... provide real-time, proactive advice and guidance. + Escalate potentially significant inspection findings/compliance risks/impact to Client Senior Management. +… more
- Bristol Myers Squibb (Devens, MA)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Senior Manager , Inspection Readiness (2)** **Position Summary** ... Reporting to the Director, Inspection Readiness , the Snr. Manager , Inspection Readiness plays a critical role in advancing the organization's … more
- Sanofi Group (Framingham, MA)
- **Job Title:** Audit and Inspection Manager **Location:** Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, ... + Reviewing the internal audit reports before submission to senior management to ensure accuracy and consistency + Ensuring...management to ensure accuracy and consistency + Ensuring an inspection readiness process is in place to… more
- Bristol Myers Squibb (Devens, MA)
- …Summary** Reporting to the Senior Director, Operations & Performance, the Senior Manager , Audit Intelligence Coordinator, is responsible for planning audits ... , Directed or For Cause, acquisitions, regulatory/agent distributors, labeling and inspection readiness . + Responsible for enhancing efficiency and simplifying… more
- ThermoFisher Scientific (Plainville, MA)
- …MA | 100% Onsite** **Position Summary:** We are in search of a forward-thinking Senior Manager for Quality to lead all aspects of the Quality Operations ... therapies. You'll provide operational quality oversight and ensure compliance and inspection readiness in-line with global regulatory standards-while shaping the… more
- Bristol Myers Squibb (Devens, MA)
- …no better place than here at BMS with our Cell Therapy team. The ** Senior Manager Quality Systems, Site Data Integrity Lead** is responsible for ownership ... room support for Health Authority Inspections and Drive site DI Inspection Readiness solutions. + Oversight of Data Integrity Risk Assessment (DIRA) program… more
- Sanofi Group (Waltham, MA)
- …Deviations/Investigations, CAPAs and Change Control. + Supports and improve (as needed) the Inspection Readiness Program. + Support and improve (as needed) the ... **Job title:** Manager , Quality Operations - Vaccine **Location:** Waltham, MA...with internal and external stakeholders while communicating proactively to senior management any issues for resolution. + Ensure the… more
- Bristol Myers Squibb (Devens, MA)
- …waste + Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness ; Actively supporting regulatory inspections + Staying current ... better place than here at BMS with our Cell Therapy team. The ** Manager , Investigations, Cell Therapy** provides investigation leadership and support to the Devens… more
- Bristol Myers Squibb (Devens, MA)
- …as part of investigations (eg Root cause analysis and CAPAs). + Support inspection readiness and actively support regulatory inspections and ensure safe and ... here at BMS with our Cell Therapy team. The ** Manager , Operational Excellence, Cell Therapy** is responsible for performing...the execution of technical projects and report out to senior management. + Implement methods for improving efficiency and… 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 ... spend related to clinical program execution. Works closely with COMs, Global Program Manager (GPM), and Finance to ensure on a regular basis that budgets, enrolment,… more
