JMD Technologies Inc. ยท 1 week ago
Senior Manager, Quality Systems Readiness (Commercial Launch)
Boston, MA
Contract
Hybrid
Senior Level, Lead/Staff
$70/hr - $75/hr
8+ years expJMD Technologies Inc. is seeking a Senior Manager, Quality Systems Readiness to support commercial launch readiness for biologics and combination products. The role involves ensuring compliance of GMP Quality Systems and documentation, partnering with various teams to drive quality execution.
Information Technology & Services
Hiring Manager
Shravan Jaisswal
Responsibilities
Lead GMP Quality Systems readiness activities for commercial biologics and combination products
Own and revise SOPs / controlled documents with heavy hands-on involvement
Manage document lifecycle, change controls, and approvals in Veeva Vault QMS
Ensure compliance with global GxP regulations (21 CFR, EU Annex 1, ISO 13485)
Partner with Manufacturing, Supply Chain, Regulatory, and QA for launch execution
Provide supplier and CMO quality oversight , including readiness and inspections
Qualification
Required
8+ years of experience in Quality Assurance / Quality Systems within biotech or pharma
Strong background in commercial biologics and/or combination products (pre-filled syringes preferred)
Demonstrated expertise in SOP authoring, revision, and governance
Hands-on experience with Veeva Vault QMS
Solid understanding of GMP and global regulatory requirements
Proven ability to work cross-functionally in fast-paced environments
Company
JMD Technologies Inc.
JMD Technologies Staffing, Recruitment and RPO service company managed with leaders having 21+ years of experience in the industry.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase