Lead Quality Specialist:
Location: Pune
Category: Clinical
Company: Fortrea
Company Overview:
Fortrea is a global contract research organization (CRO) specializing in clinical development, regulatory affairs, patient access, and technology solutions. Operating in nearly 100 countries, Fortrea serves pharmaceutical, biotechnology, and medical device companies across 20+ therapeutic areas, transforming drug and device development worldwide.
Role Overview:
The Lead Quality Specialist will be responsible for ensuring the quality of deliverables, implementing quality processes, and serving as a key contact for regulatory updates and quality standards within assigned projects. This role requires expertise in quality management and regulatory compliance, along with strong analytical and problem-solving skills.
Key Responsibilities:
Quality Assurance & Process Implementation:
Assume accountability for the quality of deliverables and implementation of quality processes with minimal support from the Manager.
Act as a process and quality expert for clients, ensuring adherence to regulatory updates, quality concepts, procedures, and best practices.
Serve as the Point of Contact for the delivery team on regulatory updates, quality standards, and industry best practices.
Quality Monitoring & Compliance:
Work with team members to analyze quality findings and develop corrective action plans.
Respond to and address periodic client quality reviews and other ad-hoc client quality findings.
Ensure compliance with industry regulations and internal quality standards.
Stakeholder Collaboration & Continuous Improvement:
Collaborate with internal teams to maintain and improve quality control frameworks.
Provide training and guidance on quality processes and compliance requirements.
Implement best practices to enhance efficiency, accuracy, and regulatory adherence.
Required Experience & Skills:
Proven experience in Quality Assurance or Quality Management within the clinical research, pharmaceutical, or biotechnology industry.
Strong understanding of regulatory compliance and quality standards applicable to clinical trials.
Experience in analyzing quality issues and implementing corrective actions.
Excellent communication and stakeholder management skills.
Ability to work independently with minimal supervision and ensure high-quality deliverables.
Strong problem-solving and analytical abilities.
Knowledge of GxP, ICH-GCP, and other relevant regulatory guidelines is preferred.
About Fortrea:
Fortrea is committed to transforming clinical trials and drug development through innovation and collaboration. The company fosters an inclusive and diverse work environment, offering employees the opportunity to make a meaningful global impact.
Equal Opportunity Employer Statement
Fortrea is an Equal Opportunity Employer (EOE/AA) and is committed to fostering diversity and inclusion. The company does not tolerate discrimination or harassment based on race, religion, gender, disability, veteran status, or any other legally protected characteristic.
For more information, visit www.fortrea.com.
If you require accommodations during the hiring process, please contact taaccommodationsrequest@fortrea.com.
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