A commercial SaaS company that works in the biotech and medtech space is looking for a Staff level Compliance Manager to come in and ensure their software products are in FDA, HIPPA, ISO, SOC, etc compliance. You'll ensure that their validation processes are aligned with their software products, handled product release management oversight, and be responsible for the organization's compliance frameworks.
Ideal candidates have experience with 21 CFR Part 11 and EU Annexx 11, as well as have developed Quality Management Systems, authored GxP Validation Packages, and have had leadership roles.
This role is 3 days hybrid in Cambridge, MA.
Required Skills & Experience - 12+ years of experience in software compliance or validation
- Experience acting as an independent senior compliance individual contributor inside a software product company
- Experience leading and hosting customer audits for top 20 pharma or biotech companies
- Direct experience with FDA 21 CFR Part 11, CSA, and GxP frameworks
- Management and leadership experience
- Strong communication skills
The Offer You will receive the following benefits:
- Medical, Dental, and Vision Insurance
- Vacation Time
- Much more
Applicants must be currently authorized to work in the US on a full-time basis now and in the future.
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