Instagram
youtube
Facebook

Lead Quality Specialist

o-2 years
Not Disclosed
10 Feb. 19, 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

Job Title: Lead Quality Specialist

Location: Pune
Category: Clinical
Job ID: 2443224


Company Overview:

Fortrea is a global contract research organization (CRO) committed to scientific rigor and decades of clinical development experience. We provide a wide range of clinical development, patient access, and technology solutions across 20+ therapeutic areas, supporting pharmaceutical, biotechnology, and medical device customers in over 100 countries. Fortrea is dedicated to transforming drug and device development to benefit partners and patients worldwide.

For more details about Fortrea, visit www.fortrea.com.


Job Overview:

The Lead Quality Specialist will assume responsibility for ensuring the quality of deliverables and the effective implementation of quality processes with minimal oversight. This role involves working closely with the delivery team to ensure regulatory updates, quality practices, and applicable procedures are followed across the assigned projects.


Summary of Responsibilities:

  • Quality Assurance: Assume accountability for the quality of deliverables and the implementation of quality processes across assigned projects.

  • Point of Contact: Serve as the main contact for the delivery team regarding regulatory updates, quality concepts, procedures, and applicable practices.

  • Client Support: Act as the process and quality expert for clients, assisting with analyzing quality findings and developing action plans.

  • Client Communication: Respond to and address periodic client quality reviews and other ad-hoc client quality concerns.


Fortrea’s Culture & Values:

Fortrea is committed to overcoming challenges in clinical trials through innovation and teamwork. We value a collaborative workspace that fosters personal growth and enables you to make a meaningful global impact. Our Fortrea FOUR culture emphasizes:

  • Forward Together

  • Own It

  • Uphold Integrity

  • Respect People


Equal Opportunity Employer:

Fortrea is an Equal Opportunity Employer (EOE/AA) and is dedicated to fostering a diverse and inclusive workforce. We do not tolerate discrimination or harassment based on race, religion, color, national origin, gender, age, disability, or any other legally protected characteristic.


Accommodation Requests:

If you require accommodations during the job application process, interview, or other aspects of the hiring process, please reach out to:
Email: taaccommodationsrequest@fortrea.com
(Note: This email is for accommodation requests only. Please do not use it for checking the status of your application.)


For more detailed information on our recruitment policies, visit Fortrea’s Privacy Statement.