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Manager, Qa (Individual Contributor Role)

10+ years years
not specified
10 Sept. 3, 2025
Job Description
Job Type: Hybrid Education: Bachelor’s degree in Life Sciences preferred 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:

Manager, QA (Individual Contributor Role)


Company:

Fortrea
🌐 www.fortrea.com


Job Details:

  • Job ID: 253951

  • Category: Regulatory / Compliance

  • Work Locations: Available in 3 locations (not specified)

  • Work Environment: Office-based (Hybrid), as directed by the line manager

  • Travel: May be required

  • Overtime: Some overtime may be required


About Fortrea:

Fortrea is a global Contract Research Organization (CRO) with operations in ~100 countries. With deep clinical development expertise and a passion for scientific rigor, Fortrea delivers innovative solutions across 20+ therapeutic areas to pharmaceutical, biotechnology, and medical device companies.

Fortrea’s Culture:

Guided by the Fortrea FOUR values:

  • Forward Together

  • Own It

  • Uphold Integrity

  • Respect People

Fortrea fosters a collaborative environment where personal and professional growth is prioritized, and where each employee can make a meaningful global impact.


Job Overview:

The Manager, QA (IC role) is responsible for managing and executing Fortrea’s global audit and inspection programs, ensuring compliance with regulatory standards and continuous improvement of internal quality systems. This role operates at a strategic and operational level, leading key audits, process improvements, and interfacing with internal stakeholders and regulatory authorities.


Key Responsibilities:

🔍 Audit Program Management

  • Oversee execution of global audit programs, ensuring compliance with the master audit plan

  • Define audit scope, lead global audits, and manage audit teams

  • Prioritize projects for risk-based audits

⚖️ Regulatory Compliance & Quality Systems

  • Ensure Standard Operating Procedures (SOPs) are implemented and adhered to consistently

  • Identify quality issues and escalate appropriately with preventive actions

  • Interpret and implement relevant quality regulations and standards

  • Ensure QA responsibilities are executed as defined in controlled documents

📈 Process Improvement & Data Analysis

  • Lead functional process improvement initiatives to drive QA efficiency and effectiveness

  • Analyze audit and quality data for trends and insights

  • Propose strategic improvements across RC and QA processes

🗣️ Stakeholder & Client Engagement

  • Negotiate and collaborate with cross-functional stakeholders to enhance quality and efficiency

  • Lead interactions with clients and regulatory agencies

  • Ensure effective communication of audit findings and recommendations

🛠️ Additional Duties

  • Perform other responsibilities as assigned by management


Qualifications:

🎓 Education (Minimum Required):

  • Bachelor’s degree in Life Sciences preferred

    Relevant and equivalent experience may be considered in lieu of a degree

💼 Experience (Minimum Required):

  • 10+ years in a regulatory environment, specifically in GXP roles

  • Direct experience conducting GCP (Good Clinical Practice) and GVP (Good Pharmacovigilance Practice) audits

  • Strong understanding of quality systems, standards, and applicable regulatory requirements

  • Experience leading process improvement projects

  • Skilled in stakeholder communication and negotiation


Preferred Qualifications:

  • Deep knowledge of global GxP compliance standards

  • Experience with international regulatory bodies

  • Demonstrated leadership in cross-functional audit initiatives


Work Environment:

  • Hybrid work model (Office-based with flexibility)

  • Some travel may be required

  • Occasional overtime may be needed to meet deadlines or audit schedules


Equal Opportunity & Accessibility:

Fortrea is an Equal Opportunity Employer. All qualified applicants will be considered without regard to:

  • Race, color, religion

  • Gender, sexual orientation, or gender identity

  • National origin, veteran status, disability, or other protected categories

Fortrea is committed to providing reasonable accommodations for individuals with disabilities during all phases of the hiring and employment process.
🔗 Learn more about EEO & accommodations


How to Apply:

📤 Job ID: 253951
📍 Available in 3 locations
🔗 Apply via the Fortrea Careers Portal

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