Lead Quality Specialist

5+ years
Not Disclosed
10 March 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: Quality Assurance Point of Contact (POC) - Regulatory and Process Expert

Company: Fortrea, a Global Contract Research Organization (CRO)

Location: [Insert Location]


About Fortrea:

Fortrea is a leading global contract research organization (CRO), driven by scientific rigor and decades of clinical development experience. We partner with pharmaceutical, biotechnology, and medical device companies to deliver 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, advancing partnerships and improving patient outcomes globally.


Position Overview:

We are looking for a Quality Assurance Point of Contact (POC) who will be responsible for ensuring the quality of deliverables and the implementation of quality processes on assigned projects with minimal support from management. As the subject matter expert on regulatory updates, quality concepts, and applicable procedures, you will serve as the primary point of contact for the delivery team, clients, and other stakeholders. Your role will involve analyzing quality findings, developing action plans, and addressing periodic client reviews and ad-hoc quality findings.


Key Responsibilities:

  • Assume accountability for the quality of project deliverables and the effective implementation of quality processes with minimal guidance from the Manager.
  • Serve as the point of contact for the delivery team, providing guidance on regulatory updates, quality concepts, and applicable procedures.
  • Act as the process and quality expert for clients, ensuring adherence to regulatory standards and best practices.
  • Collaborate with team members to analyze quality findings and help develop corrective action plans.
  • Take ownership of responding to and addressing periodic client quality reviews and any ad-hoc client quality findings.
  • Maintain clear communication with internal teams and clients to ensure quality compliance and continuous improvement.

Why Join Fortrea?

Fortrea is dedicated to fostering a dynamic and collaborative environment where motivated problem-solvers can grow and make a meaningful global impact. Our unwavering commitment to revolutionizing the development process ensures that life-changing therapies reach patients in need. By joining Fortrea, you will have the opportunity to work in a supportive environment that nurtures both your professional and personal growth.


Fortrea is an Equal Opportunity Employer:

As an Equal Opportunity Employer (EOE/AA), Fortrea is committed to diversity and inclusion in the workforce. We do not tolerate harassment or discrimination of any kind. We base employment decisions on the qualifications and needs of our business and encourage candidates from all backgrounds to apply.

For more information about how we collect and store your personal data, please refer to our Privacy Statement.

If you require reasonable accommodations due to a disability to complete your application, pre-employment testing, interview, or participate in the hiring process, please contact us at: taaccommodationsrequest@fortrea.com. This email address is for accommodation requests only and should not be used to check the status of your application.


Apply Now and Make a Global Impact at Fortrea!