Senior Quality Ops & Compliance Lead - Regulated SaaS

SimplerQMS; Philippines; On-site; PHP 1,800,000 - 2,400,000; Full time

Benefits offered by this job

Remote-first

International team

Flexible hours

Audit readiness focus

Job summary

SimplerQMS, a Danish-founded SaaS company providing a validated eQMS platform for life-science firms, seeks a Senior Quality Operations & Compliance Specialist. You will act as operational authority within Quality Operations, bridging QA, Customer Success, Product, Sales, and Onboarding to keep QMS and ISMS audit-ready and scalable.

In this role, you will govern CAPA, non-conformance, audits, supplier quality, training governance, and regulatory alignment, ensuring processes remain pragmatic and

Qualifications

• Strong understanding of ISO 13485, ISO 27001, and GxP principles.
• Experience with CAPA systems, audits, and supplier quality activities.
• Experience leading internal and customer audits.
• Root cause analysis and structured problem-solving skills.
• Ability to collaborate across QA, Product, Customer Success, Sales, and Operations.
• Strong written and verbal English communication skills.

Responsibilities

• Govern operational QMS and ISMS activities including CAPA and non-conformance handling.
• Coordinate internal, customer, ISO, and supplier audits.
• Maintain scalable, audit-defensible quality processes.
• Collaborate with QA leadership and cross-functional teams.

Skills

ISO 13485

ISO 27001

GxP

CAPA

Audit processes

Supplier controls

Risk management

Root cause analysis

Cross-functional collab

English communication

Education

Bachelor's degree in Life Sciences, Pharmacy, Engineering, Quality Management, Regulatory Affairs, or related discipline

Tools

QMS software

Job description

SimplerQMS, a Danish-founded SaaS company providing a validated eQMS platform for life-science firms, seeks a Senior Quality Operations & Compliance Specialist. You will act as operational authority within Quality Operations, bridging QA, Customer Success, Product, Sales, and Onboarding to keep QMS and ISMS audit-ready and scalable.

In this role, you will govern CAPA, non-conformance, audits, supplier quality, training governance, and regulatory alignment, ensuring processes remain pragmatic and