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Lead Quality Specialist

2+ years
Not Disclosed
10 Feb. 13, 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

Location: Pune
Category: Clinical
Job ID: 2443224

Description:
Fortrea, a global contract research organization (CRO) with a strong commitment to scientific rigor and decades of clinical development experience, offers pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in approximately 100 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

Key Responsibilities:

  • Assume accountability for the quality of deliverables and the implementation of quality processes with minimal support from the Manager.
  • Function as a Point of Contact for the delivery team regarding regulatory updates, quality concepts, applicable procedures, practices, and conventions on assigned projects.
  • Act as the process and quality expert for the client.
  • Work with other team members to analyze quality findings and help develop action plans.
  • Take ownership of responding to and addressing periodic client quality reviews and other ad-hoc client quality findings.

Fortrea seeks motivated problem-solvers and creative thinkers who share a passion for overcoming barriers in clinical trials. The organization is dedicated to revolutionizing the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Fortrea offers a collaborative workspace that fosters personal growth and global impact.

Equal Opportunity Employer Statement:
Fortrea is an Equal Opportunity Employer committed to diversity and inclusion in the workforce. Discrimination and harassment of any kind are not tolerated. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital status, sexual orientation, gender identity or expression, age, veteran status, disability, genetic information, or any other legally protected characteristic. All qualified candidates are encouraged to apply.

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

Privacy & Accommodation Requests:
For details on how Fortrea collects and stores personal data, please refer to its Privacy Statement. If you require a reasonable accommodation during the hiring process, please contact:
taaccommodationsrequest@fortrea.com. This email is strictly for accommodation requests and should not be used to check application status.