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Qa Lead

Fortrea
Fortrea
8 years
Not Disclosed
10 Sept. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Job Title: QA Lead

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


Job Summary:

The QA Lead is responsible for supporting quality management activities within the organization, including tracking quality issues, supporting CAPA creation, and ensuring compliance with QMS and GXP standards. The role involves collaboration with internal teams and leadership, as well as client communications where applicable.


Key Responsibilities:

1. Quality Management & Case Tracking:

  • Work with internal teams to progress quality issues within the QMS.

  • Track timeliness of cases in QMS.

  • Maintain a strong working knowledge of QMS.

2. CAPA & Metrics Support:

  • Support teams in the creation of Corrective and Preventive Actions (CAPAs).

  • Assist QA Lead Manager and above in pulling metric data, trending, and tracking of Quality Issues (QI).

3. Communication & Collaboration:

  • Interact with QA Lead Manager and above for quality issue progression and client notifications.

  • Convey key details of quality issues internally.

  • Communicate quality issue summaries to clients, where applicable.

4. Additional Responsibilities:

  • Perform all other duties as needed or assigned.


Minimum Requirements:

  • Education: Bachelor’s degree in Life Sciences preferred, or equivalent Life Science experience.

  • Experience:

    • Minimum 8 years in a regulatory environment, including GXP roles.

    • Strong understanding of QMS and CAPA processes.

    • Knowledge of GCPs/GXPs.

  • Skills:

    • Ability to work effectively within a team environment.

    • Strong communication skills for internal and client-facing interactions.


Preferred Qualifications:

  • Relevant and equivalent experience may be considered in lieu of formal educational requirements.


Physical Demands / Work Environment:

  • Travel may be required.

  • Office-based (Hybrid), as requested by the line manager.


Additional Information: