Software Product Compliance Manager - BioTech/SaaS/Cambridge, MA
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 compliance, quality, or regulatory roles within biotech, pharma, or life sciences
- Strong experience with software product compliance (GxP, CSV, FDA guidelines)
- Experience working closely with product and engineering teams
- Knowledge of software development lifecycle in regulated environments
- Strong communication and stakeholder management skills
Preferred Qualifications
- Experience with SaaS or digital health products in biotech
- Familiarity with validation tools and documentation systems
- Relevant certifications (e.g., CQA, RAC)
The Offer
- Competitive compensation package
- Comprehensive benefits (medical, dental, vision)
- PTO and retirement plan
Eligibility Applicants must be authorized to work in the United States without sponsorship. Posted By: Erin White