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Lead Quality Specialist

0-2 years
Not Disclosed
10 Jan. 18, 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

Position: Lead Quality Specialist
Location: Pune
Category: Clinical
Job ID: 2443227


Job Overview

As a Lead Quality Specialist at Fortrea, you will take ownership of the quality of deliverables for clinical trials, ensuring the implementation of quality processes with minimal support. You will serve as the point of contact for regulatory updates, quality concepts, procedures, and practices on assigned projects, as well as the process and quality expert for clients. This position requires expertise in analyzing quality findings and developing action plans, while also responding to client quality reviews and findings.

Key Responsibilities

  • Quality Accountability: Assume full accountability for the quality of deliverables and the implementation of quality processes across projects.
  • Client Interaction: Act as the point of contact for regulatory updates, quality concepts, applicable procedures, and practices. Serve as the process and quality expert for the client.
  • Quality Analysis: Collaborate with team members to analyze quality findings, develop action plans, and implement improvements.
  • Client Reviews: Own the response to periodic client quality reviews and address any ad-hoc client quality findings.
  • Process Improvement: Identify and drive process improvements to ensure consistent quality in deliverables.

Required Qualifications

  • Experience: Previous experience in quality management within clinical trials or related fields.
  • Expertise: In-depth knowledge of regulatory guidelines, quality management systems, and clinical trial processes.
  • Communication Skills: Strong ability to communicate quality-related issues, solutions, and improvements to clients and internal teams.
  • Problem-Solving Skills: Ability to analyze complex quality data and develop actionable solutions.

Company Overview

Fortrea is a leading global contract research organization (CRO) that provides clinical development, patient access, and technology solutions in over 20 therapeutic areas. With operations in approximately 100 countries, Fortrea is committed to transforming drug and device development, ensuring the rapid delivery of life-changing therapies to patients worldwide.

Equal Opportunity Employer Statement

Fortrea is an Equal Opportunity Employer that fosters diversity and inclusion. We are committed to providing a harassment-free and discrimination-free environment for all employees. Employment decisions are based on business needs and individual qualifications. All qualified applicants are encouraged to apply.

Accommodation

Fortrea provides reasonable accommodations for individuals who need assistance in the hiring process. Please reach out to taaccommodationsrequest@fortrea.com if you require accommodation during the application or interview process.\