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Lead Quality Specialist

4+ years
Not Disclosed
10 Jan. 28, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: 2443227


About Fortrea

Fortrea is a global contract research organization (CRO) dedicated to scientific rigor and clinical development. Supporting pharmaceutical, biotechnology, and medical device clients, Fortrea offers clinical development, patient access, and technology solutions across 20+ therapeutic areas. Operating in nearly 100 countries, Fortrea aims to revolutionize drug and device development for global partners and patients.


Key Responsibilities

Quality Accountability and Oversight

  • Assume accountability for the quality of deliverables and ensure the implementation of quality processes with minimal support from the manager.
  • Function as the point of contact for the delivery team regarding:
    • Regulatory updates
    • Quality concepts
    • Applicable procedures, practices, and conventions specific to assigned projects.

Client and Process Expertise

  • Act as the process and quality expert for the client, providing insights and recommendations as needed.
  • Respond to and address periodic client quality reviews and ad hoc quality findings, ensuring effective resolutions.

Quality Analysis and Action Planning

  • Collaborate with team members to analyze quality findings and assist in developing and implementing action plans for improvement.

Candidate Profile

Fortrea seeks motivated problem-solvers and creative thinkers who are passionate about overcoming barriers in clinical trials. The ideal candidate will have:

  • A deep commitment to maintaining the highest quality standards.
  • The ability to act independently while fostering collaboration across teams.
  • A proactive approach to addressing quality challenges and driving improvements.

Why Join Fortrea?

  • Opportunity to make a global impact in clinical trials and drug development.
  • A collaborative and inclusive environment that fosters personal and professional growth.
  • Access to innovative projects in the clinical development space.

Equal Opportunity Employer

Fortrea is an Equal Opportunity Employer (EOE/AA) committed to diversity and inclusion. Employment decisions are made based on qualifications and business needs, without discrimination based on legally protected characteristics.

For reasonable accommodation requests, contact taaccommodationsrequest@fortrea.com.

For more information, visit www.fortrea.com.