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Qa Lead

8 years
Not Disclosed
10 Nov. 25, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

QA Lead – Regulatory & Compliance

Locations: Multiple (3 Locations Available)
Category: Regulatory / Compliance
Job ID: 254012

Position Overview

The QA Lead is responsible for supporting and strengthening Quality Management System (QMS) operations within the organization. This role plays a key part in driving compliance, ensuring timely case progression, supporting Corrective and Preventive Actions (CAPAs), and providing data-driven insights for quality improvement. The QA Lead works closely with cross-functional teams and Quality leadership to maintain regulatory standards and ensure consistency across quality processes.

This position is well-suited for experienced quality professionals seeking a leadership-oriented role within a regulated environment.


Key Responsibilities

  • Support internal teams in resolving and progressing quality issues within the QMS.

  • Monitor and track case timelines to ensure compliance with QMS requirements.

  • Assist teams in the creation, documentation, and closure of CAPAs.

  • Maintain a strong understanding of the Quality Management System and its processes.

  • Coordinate with the QA Lead Manager and senior leadership to manage quality case progress and client communications.

  • Support leadership with data extraction, metric reporting, trend analysis, and tracking of quality issues.

  • Ensure effective communication of quality concerns across internal teams.

  • Communicate summaries of quality issues to clients when required.

  • Perform additional responsibilities as assigned to support continuous quality improvement.


Required Qualifications

  • Bachelor’s degree in Life Sciences or equivalent relevant experience.

  • Minimum 8 years of experience in a regulatory or compliance-based environment, preferably within GxP functions.

  • Strong understanding of QMS operations, CAPA processes, and regulatory frameworks.

  • Knowledge of GCP/GxP standards and regulatory expectations.


Preferred Skills & Experience

  • Ability to work effectively within cross-functional teams.

  • Strong communication and documentation skills to convey key quality-related information.

  • Experience preparing quality summaries for clients or regulatory partners.

  • Analytical mindset with the ability to extract, trend, and interpret metric data.

  • Fortrea may consider equivalent experience in place of formal education.


Work Environment

  • Hybrid office-based role as directed by the line manager.

  • Travel may be required based on project or client needs.