Staff Compliance Manager / GxP

About the role

The ideal candidate will ensure that the company's software products comply with FDA, HIPAA, ISO, SOC, and other relevant regulations. They will oversee validation processes aligned with software products, manage product release oversight, and lead the organization's compliance frameworks.

Responsibilities

• Ensure compliance with FDA, HIPAA, ISO, SOC, and other relevant regulations
• Oversight of validation processes aligned with software products
• Product release management oversight
• Led and hosted 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

Requirements

12+ years of experience in software compliance or validation

Experience acting as an independent senior compliance individual contributor inside a software product company

Direct experience with FDA 21 CFR Part 11, CSA, and GxP frameworks

Management and leadership experience

Strong communication skills

Qualifications

Not specified

Skills

• Experience with 21 CFR Part 11 and EU Annexx 11
• Developed Quality Management Systems
• Authored GxP Validation Packages
• Led and hosted customer audits for top 20 pharma or biotech companies

Benefits

Medical, Dental, and Vision Insurance

Vacation Time

Many more benefits

Not specified

Pay

Not specified

Schedule

3 days hybrid in Cambridge, MA