Job Title: Quality Manager, cFSP
Location: Durham, North Carolina
Job ID: R1477699
Job Type: Full Time
Job Overview:
The Quality Manager for cFSP will lead quality collaborations within the clinical trial teams and operational functions, working with both regional and global stakeholders. They will drive continuous improvement in quality processes, maintain inspection readiness, and ensure compliance with regulatory and GCP standards. The role requires strategic leadership and close collaboration with study teams and stakeholders to mitigate risks and support quality deliverables.
Role-Specific Responsibilities:
Serve as the point of contact for regional quality and compliance queries.
Review and consult on the development or revision of SOPs and WIs.
Facilitate collaborations with Global Monitoring, Clinical Study Support, and Regional Clinical Operations.
Provide support and consultation for quality management within assigned clinical trials.
Identify and assess potential quality issues, recommending escalations as needed.
Offer training and coaching to study teams to ensure adherence to quality standards.
Work with teams and CROs to resolve quality issues and ensure compliance.
Support inspection readiness activities in preparation for regulatory inspections.
Assist in preparation, execution, and follow-up of regulatory inspections.
Review audit reports to propose process improvements.
Contribute to the development of Key Quality Indicators (KQI) to identify trends and assess adherence to quality standards.
General Responsibilities:
Develop and maintain guidance to support Study Teams with quality management.
Contribute to the development and dissemination of GCP Lessons Learned and trending analysis.
Provide training or awareness for new or established DOQ processes.
Lead and facilitate assigned workstreams or DOQ initiatives.
Collaborate in identifying opportunities for continuous improvement in processes and quality metrics.
Stay current on clinical trial requirements, ICH GCP guidelines, and global regulatory requirements.
Skills/Experience:
Knowledge of Quality Management methods and relevant procedures.
Experience in managing quality within large, complex multinational clinical trials.
Expertise in risk and issue management, including assessing non-compliance with GCP and regulatory standards.
Ability to develop and contribute to processes, SOPs, and WIs.
Experience with audits, inspections, and regulatory compliance activities.
Familiarity with all phases of clinical trials, with regulatory knowledge preferred.
Minimum Requirements:
Bachelor’s degree preferred or equivalent experience.
Minimum of 5 years of experience in a pharmaceutical, bio-pharmaceutical, or CRO environment.
At least 5 years of experience in a quality management role.
Working knowledge of ICH GCP and relevant regulatory/health authority guidelines.
Ability to travel as needed.
Compensation:
Annual Salary Range: $103,900.00 - $173,100.00
Compensation may vary based on experience, location, and role-specific factors. Incentives, bonuses, and benefits may also be included.
About IQVIA:
IQVIA is a global leader in clinical research services, providing insights and intelligence to accelerate the development of innovative medical treatments and improve patient outcomes.
Equal Opportunity Employer:
All applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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