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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