Instagram
youtube
Facebook

Manager, Qa (Ic Role)

10+ years
Not Disclosed
10 July 31, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.harm/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

 

Manager, QA (IC Role)

Location: India (3 Locations)
Work Mode: Hybrid (Office-based, as requested by manager)
Experience Level: Senior (10+ years)
Job Type: Full-time
Salary/Compensation: Not specified


Job Summary

Fortrea, a leading global CRO, is hiring a seasoned Manager, QA to lead global audit and inspection programs in compliance with GxP standards. With over 10 years of regulatory quality experience, the ideal candidate will drive continuous improvement, conduct GCP and GVP audits, and serve as a key liaison with regulatory agencies and stakeholders. This hybrid opportunity allows you to make a meaningful impact across global quality systems in the pharmaceutical and biotechnology sectors.


Key Responsibilities

  • Lead and manage global audit programs aligned with the master audit plan

  • Identify scope and lead global audits and audit teams

  • Oversee SOP implementation and compliance monitoring

  • Escalate issues and implement corrective/preventive actions

  • Collaborate with internal stakeholders to enhance quality and efficiency

  • Analyze data to drive process improvements in RC and QA

  • Represent QA in interactions with clients and regulatory authorities

  • Develop and update policies and procedures to meet regulatory standards

  • Ensure RC and QA duties are followed as per controlled documents

  • Perform other tasks as required by management


Required Skills & Qualifications

  • Bachelor’s degree in Life Sciences preferred (or equivalent experience)

  • 10+ years of experience in regulatory environments with focus on GxP roles

  • Proficiency in conducting GCP and GVP audits

  • In-depth knowledge of global industry quality systems and regulatory standards

  • Proven ability to lead quality improvement projects and stakeholder engagement

  • Strong communication, negotiation, and regulatory interpretation skills

  • Experience with data-driven quality improvements

  • Flexible to travel and occasional overtime work

  • Fortrea may consider relevant experience in place of formal education


Perks & Benefits

  • Hybrid working model with global collaboration

  • Lead mission-critical audits and compliance programs

  • Opportunities for leadership in global quality strategy

  • Exposure to cutting-edge technologies in regulatory environments

  • Be part of a purpose-driven culture that values integrity, innovation, and impact

  • Travel opportunities to global clinical and regulatory sites


Company Description

Fortrea is a top global Contract Research Organization (CRO), offering advanced clinical development and regulatory solutions across 100+ countries. With expertise spanning 20+ therapeutic areas, Fortrea supports pharma, biotech, and medical device clients in bringing life-changing treatments to market faster and with compliance excellence.


Work Mode

Hybrid (Office-based as per line manager request)
Travel: May be required
Shift: Standard business hours, some overtime as needed


Call to Action

Join Fortrea and lead global regulatory compliance that transforms patient access to safer, effective therapies.
Apply now to become a key player in global QA excellence at Fortrea.