Director of Quality, Compliance & AI Governance

Ketryx Corporation; Boston (MA); Hybrid; USD 150,000 - 185,000; Full time

Benefits offered by this job

Generous PTO

Equity options

Competitive compensation

Job summary

Ketryx, headquartered in Boston, MA, is seeking a Director of Quality to own the QMS and ISMS, guide AI governance, and drive certification readiness for multiple standards in a regulated software environment.

You will lead a QA/RA consulting team, coordinate release governance, and partner with Engineering, Product, Security, and Sales to enable secure, compliant product delivery for enterprise customers.

Qualifications

• 10+ years of quality experience in regulated life sciences
• Experience owning or leading QMS and supporting external audits
• Experience with ISMS under ISO/IEC 27001 or equivalent
• Strong risk-based quality practices and release governance
• Clear communicator with strong documentation skills

Responsibilities

• Own the QMS and support ISMS, aligning policies, SOPs, and records with ISO/IEC standards
• Lead AI governance, policies, and conformity with ISO/IEC 42001
• Run readiness and execution for multiple certifications and audits
• Define risk-based gates and evidence expectations for releases
• Support customer questionnaires, RFPs, and strategic accounts with compliance needs
• Monitor emerging regulations and translate into guidance for internal and external teams
• Lead QA/RA consulting team, set deliverable standards and review quality work
• Collaborate with Engineering, Product, Security, Sales and leadership, representing Ketryx externally

Skills

QMS ownership

ISMS management

Regulatory audits

Risk-based governance

Technical communication

Tools

ISO 27001

SOC 2

ISO 13485

ISO 62304

ISO 26262

Job description

Ketryx, headquartered in Boston, MA, is seeking a Director of Quality to own the QMS and ISMS, guide AI governance, and drive certification readiness for multiple standards in a regulated software environment.

You will lead a QA/RA consulting team, coordinate release governance, and partner with Engineering, Product, Security, and Sales to enable secure, compliant product delivery for enterprise customers.