arrangements are not accepted. This role is hybrid in Boston, MA. POSITION SUMMARY The Inspection Readiness Manager role... is responsible for managing real-time inspection readiness activities supporting GMP and GDP quality. The role requires the ability...
approaches that support business outcomes, regulatory compliance, and inspection readiness, while partnering closely with Quality..., scalable, and aligned with inspection expectations. Regulatory Alignment & Inspection Readiness Ensure learning materials...
of work Ensure clinical project audit and inspection readiness through the study lifecycle Supports internal audit... and external inspection activities and contributes to CAPAs as required Manages and oversees study close-out activities including...
, regulations, support inspection readiness of all regulated activities. Lead or participate in special projects and initiatives... of what is possible to bring life-changing therapies to patients worldwide. Objective / Purpose: The Senior Manager, Clinical Partner...
process as well as the inspection readiness process. The position must work cross-functionally across the organization...Job Description: The Sr Manager for regulatory surveillance will support the regulatory surveillance and intelligence...
, and standardized tools while maintaining a continuous state of inspection readiness for all programs. Key Responsibilities: Lead... documentation and associated risk management systems and tools ensuring a continuous state of inspection readiness. Drive...
. Participate in inspection readiness activities and support regulatory site inspections including act as quality SME for facility...Job Description General/Position Summary The Senior Manager, Quality Assurance Technical Services will execute...
leadership. Ensure inspection readiness through complete, accurate, and readily retrievable documentation. Partner with GPSRM...Title: Senior Manager, Medical Research Location: Cambridge, MA Duration: 6+ Months Description: The Senior...
management study inspection readiness activities and the support of submission activities as needed. Train and mentor DM staff... Manager, Data Management acts as the Lead Data Manager for multiple clinical studies and/or a clinical development program...
for clinical systems, contributing to system requirements and ensuring readiness for study conduct Ensure inspection readiness... commercializes IBSRELA in Canada. The Senior Clinical Trial Manager (Senior CTM) provides strategic and operational leadership...
a strategic and execution-focused Manager, Renewal Accounts to lead a team of Renewal Account Managers across multiple experience... a high-quality customer renewal experience. Impact The Manager, Renewal Accounts plays a critical role in Rapid7...
and regulatory expectations; contribute to a culture of inspection readiness, including participation in audit/inspection preparation.... Beneficial would be knowledge of EU and US CMC requirements and familiarity with inspection expectations (e.g., MHRA/FDA...
where all people feel valued and empowered. As tenure and readiness increase, you will take on greater accountability for supporting... acuity to perform activities such as: transcribing, viewing a computer terminal, reading, visual inspection involving small...
where all people feel valued and empowered. As tenure and readiness increase, you will take on greater accountability for supporting... acuity to perform activities such as: transcribing, viewing a computer terminal, reading, visual inspection involving small...
inspection data for site(s) responsible for to ensure readiness for the yearly property inspection. Will be expected... and maintenance of the building. Manages the building engineering staff in conjunction with the Property Manager. Responsible...
to sales methodology, deal execution, pipeline rigor, and sales manager effectiveness. You will establish a repeatable, data..., certification, and readiness Ensure enablement programs remain tightly aligned to product innovation and GTM changes Coaching...
Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site... should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com...
. Responsible for the maintenance of all documentation to ensure a consistent state of regulatory readiness for all expected... Director and LIP, during scheduled or unscheduled regulatory visits (i.e., annual state/MQSA inspection). Acts regularly...
priorities, actions, and follow-through across the RDQ LT. Partner with Compliance, Inspection Readiness, Clinical Quality... visibility into quality performance metrics and readiness indicators. Act as a “go-to” partner to the Senior Director...
) is responsible for strategic and operational oversight of key activities such as inspection readiness, the GCQ operational framework... of the application of inspection readiness principles in a clinical trial setting. This position reports directly to the...