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Qa Lead

8+ 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 Management System (QMS) Specialist

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


About Fortrea:

Fortrea is a leading global contract research organization (CRO) that has spent decades delivering scientific excellence and clinical development expertise. We partner with pharmaceutical, biotechnology, and medical device companies to provide comprehensive clinical development, patient access, and technology solutions across over 20 therapeutic areas. Operating in nearly 100 countries, Fortrea is dedicated to transforming drug and device development, benefiting both partners and patients worldwide.


Position Overview:

We are seeking a motivated and experienced individual to join our team as a Quality Management System (QMS) Specialist. This role will focus on progressing quality issues within the QMS, supporting the creation and management of Corrective and Preventive Actions (CAPAs), and ensuring compliance with regulatory standards. The ideal candidate will have strong experience in regulatory environments, especially in GxP, and an in-depth understanding of QMS and CAPA processes.


Key Responsibilities:

  • Collaborate with internal teams to address and progress quality issues within the QMS.
  • Track the timeliness of quality cases in the QMS and ensure effective resolution.
  • Assist teams in the creation, implementation, and monitoring of CAPAs.
  • Maintain up-to-date knowledge of QMS standards and best practices.
  • Work closely with the QA Lead Manager and senior leadership to progress quality issue cases and communicate with clients, when applicable.
  • Support the QA team in gathering, trending, and analyzing key metric data for quality issues.
  • Take on other responsibilities as needed or assigned.

Qualifications:

Minimum Required Education:

  • A bachelor’s degree in Life Sciences (preferred), or equivalent experience in a related field. Fortrea may consider relevant experience in place of formal educational requirements.

Minimum Required Experience:

  • At least 8 years of experience in a regulatory environment, with a focus on GxP roles.
  • Strong understanding of QMS processes, including CAPA management.
  • Ability to collaborate and work effectively within a team environment.
  • Proficiency in communicating quality issues internally and summarizing them for client notifications.
  • Knowledge of Good Clinical Practices (GCPs) and Good Manufacturing Practices (GxPs).

Physical Demands & Work Environment:

  • This role involves long hours of sitting in front of a computer terminal.
  • Travel may be required based on business needs.

Why Join Fortrea?

At Fortrea, we believe in the power of problem-solving and creativity. Our team is dedicated to overcoming barriers in clinical trials and ensuring that life-changing therapies reach patients swiftly. As part of our collaborative work environment, you will have opportunities for personal growth while making a meaningful global impact.


Fortrea is an Equal Opportunity Employer:

We are committed to fostering diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are made based on business needs and the qualifications of the individual. We encourage all qualified candidates to apply, regardless of race, religion, gender, sexual orientation, disability, or any other legally protected status.


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

If you need a reasonable accommodation to apply, please contact us at: taaccommodationsrequest@fortrea.com. Please note, this email address is only for accommodation requests related to the hiring process, and not for checking the status of your application.


Apply Now and Be a Part of the Fortrea Team!