- Takeda Pharmaceuticals (Boston, MA)
- …**_GOALS:_** + Project manage and facilitate cross-functional study execution teams' GCP inspection readiness and inspection activities, including strategies ... audits and inspections. + Manage cross-functionally to assure aligned approach to inspection readiness strategy with Clinical Quality Assurance (CQA) and Global… more
- Takeda Pharmaceuticals (Boston, MA)
- …represent function in a formal inspection or audit. + Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. + ... the best of my knowledge. **Job Description** Objective / Purpose: The Senior Manager Clinical Data Management is responsible for timely and high quality data… more
- MIT Lincoln Laboratory (Lexington, MA)
- …They are also tasked with ensuring that both networks are kept at an inspection ready status. Maintaining inspection readiness involves developing a strong ... will coordinate the actions of the team to maintain inspection ready status, they will interface with the CES...Expected qualifications for the position include + An experienced manager of IT professionals possessing critical thinking skills and… more
- Rhythm Pharmaceuticals (Boston, MA)
- …clinical trials. The individual will lead and/or support GCP audits, maintain inspection readiness , and manage key relationships internally and externally. This ... to overcome barriers, together. Opportunity Overview The Clinical Quality Assurance Manager will oversee GCP activities across various areas of development, ensuring… more
- Harvard University (Cambridge, MA)
- …and training on regulatory submission activities, processes, and deliverable + Audit/ inspection readiness Assisting project leadership with: + Development of ... Office Location:USA - MA - Boston Business Title:Biostatistician/Statistical Project Manager for Regulatory Submission StudiesSub-Unit: Appointment End Date:30-Nov-2027Salary Grade… more
- Bristol Myers Squibb (Devens, MA)
- …of the revalidation and cleaning monitoring programs. + Responsible for regulatory inspection readiness and guidance to ensure cleaning validation and cleaning ... in their personal lives. Read more: careers.bms.com/working-with-us . **Position:** Manager , Cleaning Validation, Validation Engineering **Location** : Devens, MA… more
- Motion Recruitment Partners (Boston, MA)
- Modernization Project Manager - Salesforce Boston, Massachusetts **Hybrid** Contract $60/hr - $80/hr **Position Summary:** A key priority initiative is the ... implementation of a unified Salesforce Licensing, Permitting, and Inspection (LPI) system to support essential business functions. To ensure the success of this… more
- Takeda Pharmaceuticals (Boston, MA)
- …provide strategic insight at global level + Participate in and support for PV audit/ Inspection and ensure its readiness with compliance and training team + ... Escalate issues / problems to line manager as needed. **Education & Competencies (Technical and Behavioral):** + Bachelor's degree in a scientific discipline or… more
- Teleflex (Chelmsford, MA)
- …Management System including CAPA & Nonconformance (NC) Processes; Incoming Inspection Improvements; Perpetual Audit readiness ; Product Complaints identified ... and CAPA processing - lead quality activities such as inspection methods, NC containment, correction, closure and CAPAs; and...Perform any additional QA tasks, as assigned by QA Manager or Plant Manager . * Maintain compliance… more
- Beth Israel Lahey Health (Beverly, MA)
- … Manager and vendors to troubleshoot instrument and QC problems. Assists Manager with CAP/Joint Commission inspection readiness , including CAP surveys ... comes with a $10,000 sign on bonus! **Position Summary:** Assists Chemistry Manager in developing, directing and coordinating section activities at both sites. Serve… more
- Philips (Cambridge, MA)
- …facilities and functions consistently operate in a state of compliance and inspection readiness ; proactively ensure all products, software, services and systems ... operational excellence & proactive regulatory compliance. + As a people manager , you are responsible for attracting, developing, engaging and retaining your… more
- Bristol Myers Squibb (Devens, MA)
- …as associated site infrastructure. + Provide IT leadership to site regulatory inspection readiness and data integrity initiatives. + Participate in high-level ... site. We are seeking a skilled and experienced IT Platform and Product Manager to oversee the IT operations at our manufacturing site. The ideal candidate… more