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Lead Quality Specialist

3+ years
Not Disclosed
10 Feb. 4, 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

Lead Quality Specialist – Pune

Category: Clinical
Job ID: 2443224

About Fortrea:

Fortrea is a global leader in contract research, renowned for its scientific rigor and extensive experience in clinical development. We provide pharmaceutical, biotechnology, and medical device clients with advanced clinical development, patient access, and technology solutions across over 20 therapeutic areas. Operating in around 100 countries, we aim to revolutionize drug and device development, improving the lives of patients worldwide.

Role Overview:

As the Lead Quality Specialist, you will be responsible for ensuring the quality of deliverables and implementing quality processes with minimal guidance. You will serve as the primary point of contact for the delivery team, regulatory updates, and quality practices for assigned projects, while acting as the process and quality expert for the client.

Key Responsibilities:

  • Take accountability for the quality of deliverables and the execution of quality processes with minimal supervision.
  • Serve as the Point of Contact for the delivery team regarding regulatory updates, quality concepts, and procedures.
  • Act as the process and quality expert for the client.
  • Collaborate with team members to analyze quality findings and help formulate corrective action plans.
  • Take ownership of responding to client quality reviews and addressing ad-hoc client quality findings.

Why Join Fortrea?

We are looking for motivated, problem-solving thinkers who are passionate about overcoming challenges in clinical trials. At Fortrea, you will be part of an exceptional team, working in a collaborative environment that fosters personal growth and global impact.

Equal Opportunity Employer Statement:

Fortrea is committed to diversity and inclusion and ensures equal employment opportunities for all individuals. We do not tolerate discrimination based on any legally protected characteristic.

For more information, visit www.fortrea.com.