Role Summary

The Senior QMS Specialist owns Quality Management System processes for an assigned domain end to end, ensuring documentation, CAPA, and audit activities meet ISO and regulatory expectations. Reporting to the Manager, Quality Management Systems (or equivalent Quality/Compliance leader within Technology), this role exists to manage the CAPA lifecycle, coordinate audit readiness, and maintain document control standards for assigned processes, working independently on most assignments. Working closely with Technology process owners and Principal QMS colleagues, the Senior QMS Specialist reviews and approves controlled documentation, manages change control records, analyzes quality metrics, and mentors QMS Specialists. Success in this role requires strong analytical judgment, clear communication, and the ability to balance compliance rigor with delivery pragmatism.

Key Responsibilities

- Own CAPA lifecycle management for assigned processes and domains: investigation support, root-cause documentation review, effectiveness-check tracking, and closure.
- Coordinate internal audit schedules and readiness activities; serve as point of contact for audit evidence collection and finding remediation tracking.
- Review and approve controlled documentation (SOPs, work instructions) for accuracy, compliance, and consistency with ISO and regulatory requirements.
- Manage change control records for assigned processes, ensuring appropriate risk assessment, approvals, and implementation verification.
- Analyze quality metrics and trends (CAPA aging, finding recurrence, training compliance) and recommend process improvements.
- Support external audits and client or regulatory quality assessments,



representing document control and QMS administration accurately.
- Mentor QMS Specialists on documentation standards, eQMS tooling, and quality processes.
- Partner with process owners across Technology to embed quality-by-design practices into new and revised procedures.
- Maintain and improve eQMS configuration and workflows in collaboration with system administrators.
- Identify and escalate systemic quality risks or recurring non-conformances to the Manager.
- Support training-program administration, ensuring role-based curricula stay current and compliance gaps are addressed.
- Contribute to continuous improvement initiatives strengthening the QMS itself.

Core Competencies

- Results & Accountability — Owns outcomes and balances quality, speed, and pragmatic judgment.
- Collaboration & Communication — Builds cross-functional trust and aligns stakeholders with clarity.
- Continuous Improvement — Challenges the status quo and applies data/technology to drive measurable progress.
- Customer Focus — Grounds decisions in real client and business value.
- Business Insight & Strategic Thinking — Connects day-to-day work to company priorities and long-term impact.
- Trust & Integrity — Acts consistently, ethically, and with high standards.

Technical / Domain Expertise

- Strong working knowledge of QMS processes: CAPA,



change control, document control, and audit management.
- Practical experience with eQMS platforms (e.g., Veeva QMS, MasterControl, TrackWise, Qualio, ETQ Reliance), including workflow configuration and reporting.
- Solid understanding of ISO 9001 and/or ISO 27001 requirements, and applicable regulatory frameworks (GxP, 21 CFR Part 11) for technology/pharma services contexts.
- Ability to analyze quality data and metrics and translate findings into actionable recommendations.
- Understanding of risk-assessment methods (e.g., FMEA) as applied to quality processes.

Strategic Capabilities

- Acts as quality advocate for assigned processes, identifying and mitigating compliance risk early.
- Balances rigor, timeliness, and business pragmatism when applying QMS requirements.
- Begins mentoring QMS Specialists on documentation and CAPA practices.

Required Qualifications

- Bachelor's degree in a related field or equivalent applied experience.
- 3–5 years of experience in quality management systems, quality assurance, or regulatory compliance, ideally within technology, pharma, or life sciences services.
- Demonstrated experience managing CAPA, document control, or change control processes end to end.
- Experience with eQMS or document management platforms.
- Strong analytical, organizational, and communication skills.

Preferred Qualifications

- Experience coordinating internal or external audits.
- ASQ Certified Quality Auditor/Improvement Associate or equivalent certification.
- Experience in a GxP or ISO-certified environment.
- Familiarity with computer system validation (CSV/CSA) concepts.

📌 Quality Assurance Analyst (Bogotá)
🏢 Safeguard Global Recruiting
📍 Bogotá