21 Cfr Part 11 Jobs

Lead global deployment, training, and validation of enterprise quality and document management systems to ensure compliant, effective user adoption across Eurofins laboratories.

Celerion is hiring an EDC Test Analyst to perform UAT and validate clinical databases and systems to ensure compliant, timely study execution across clinical trials.

AbbVie is hiring an API Application Support Specialist to troubleshoot and optimize application interfaces and lead technical projects in a hybrid Lake County role.

Lead the strategy and full lifecycle of IT and digital capabilities for Process Development and MSAT to enable secure, compliant, and advanced manufacturing at scale.

Lead the design, deployment, and validation of Scitara DLX and LIMS integrations to automate instrument data flows and ensure GxP-compliant lab informatics operations at Moderna's Norwood site.

Experienced Computer Systems Validation Engineer needed to author and execute validation artifacts, lead client requirements, and ensure compliant system deployment for pharmaceutical and device clients in a primarily remote contract role.

Lead enterprise pharma accounts to deliver Big Data, analytics, and AI solutions as a Senior Account Director based in Boston.

Inclusive & Diverse

Rise from Within

Mission Driven

Diversity of Opinions

Family Medical Leave

Maternity Leave

Paternity Leave

Lactation Facilities

Family Coverage (Insurance)

Medical Insurance

Dental Insurance

Vision Insurance

Mental Health Resources

Life insurance

Disability Insurance

Health Savings Account (HSA)

Flexible Spending Account (FSA)

401K Matching

Paid Time-Off

Paid Volunteer Time

Lead product strategy and roadmap for Vault Clinical Operations to deliver enterprise SaaS solutions that accelerate clinical trials and improve patient outcomes.

Edwards Lifesciences is hiring a Senior Director of Injection Molding to lead worldwide engineering strategy, supplier qualification, and scale-up of compliant injection-molded components for medical devices.

Lead Moderna’s global GxP IT/OT support function to build compliant, audit-ready ITSM processes and a high-performing support team across manufacturing and lab operations.

Support AbbVie's Worcester manufacturing operations as an Automation Engineer responsible for PLC/HMI/SCADA development, commissioning, validation and ongoing troubleshooting in a cGMP environment.

Senior Director of Product Management to lead strategy and execution for patient support and engagement solutions at a healthcare-focused technology company.

Experienced statistical programming manager needed to lead SAS-based dataset and output development, QC, and CRO oversight for clinical trials at REGENXBIO in Rockville, MD.