Software Product Compliance Manager - BioTech/SaaS/Cambridge, MA

$150000 - $170000
**Job Description**
An established biotech organization is seeking a Senior Compliance Manager to lead compliance for software products supporting regulated environments. This role focuses on ensuring adherence to applicable regulatory standards across the product lifecycle (e.g., development, validation, and release), partnering closely with product, engineering, and quality teams. This is not a security-focused role.

**Key Responsibilities**

+ Lead compliance strategy for software products in regulated biotech environments
+ Ensure alignment with applicable regulations (e.g., GxP, FDA, CSV)
+ Oversee software validation and compliance documentation processes
+ Partner with product and engineering teams to embed compliance into SDLC
+ Monitor regulatory updates and assess impact on software products
+ Support internal/external audits and remediation efforts

**Required Skills & Experience**

+ 7+ years in complia...