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Lead Quality Specialist

0-2 years
Not Disclosed
10 April 10, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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: Lead Quality Specialist

Location: Pune
Category: Clinical
Job ID: 2443224


Company Overview

Fortrea is a global contract research organization (CRO) with a presence in approximately 100 countries. It provides a comprehensive suite of clinical development, patient access, and technology solutions across 20+ therapeutic areas, partnering with pharmaceutical, biotech, and medical device companies.


Job Overview

Assume accountability for the quality of deliverables and the implementation of quality processes with minimal managerial support. Act as the quality and process expert for assigned projects, ensuring adherence to regulatory standards and internal procedures.


Key Responsibilities

  • Take full accountability for the quality of project deliverables.

  • Implement and ensure compliance with quality processes with minimal supervision.

  • Serve as the primary point of contact for regulatory updates, procedures, and quality-related concepts for the delivery team.

  • Act as the process and quality expert on behalf of the client.

  • Analyze quality findings and collaborate with team members to develop corrective action plans.

  • Respond to periodic client quality reviews and address any ad-hoc quality findings.


Fortrea’s Workplace Culture

Fortrea values motivated problem-solvers and creative thinkers who are passionate about overcoming clinical trial challenges. The company fosters a collaborative and growth-focused work environment aimed at delivering life-changing treatments to patients.


Equal Opportunity Employment Statement

Fortrea is committed to fostering diversity and inclusion. Employment decisions are based solely on business needs and applicant qualifications. The company does not discriminate based on any legally protected characteristic.


Work Environment

  • Based in Pune

  • Reasonable accommodations for application and hiring processes are available upon request.


Additional Info

For more details, visit: www.fortrea.com
For accommodation requests: taaccommodationsrequest@fortrea.com