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

Boston, MA, US • Posted 3 days ago • Updated 59 minutes ago
Full Time
On-site
$150000 - $170000/yr
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Mergers and Acquisitions
  • Product Engineering
  • Management
  • Verification And Validation
  • Software Development Methodology
  • Auditing
  • Pharmaceutics
  • Life Sciences
  • Regulatory Compliance
  • GxP
  • Computerized System Validation
  • Software Development
  • Communication
  • Stakeholder Management
  • SaaS
  • Documentation
  • RAC

Summary

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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10105282
  • Position Id: 879252
  • Posted 3 days ago
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