Director, Global CRO Quality
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Job Description
Director managing Quality Management Systems and Clinical Systems at NAMSA for medical devices. Ensuring compliance with industry standards and regulations across multiple locations.
Responsibilities:
- Manages the Quality Management System(s) and Clinical Systems (GCP) at NAMSA.
- Ensure compliance of the QMS and GCP regulations to all relevant industry standards and regulations.
- Drives Quality System integration activities for NAMSA acquired CRO entities working in conjunction with CRO Operational Leaders, QA Intergation Lead and VP QA/RA.
- Works closely with all Quality and business leaders when quality issues arise, ensuring proper trending, investigation, and closure of quality events.
- Implement key process indicators in alignment with organizational goals for quality processes, sets goals, monitor, trend and report.
- Will serve as a Management representative for CRO Business unit.
- Lead Management review meetings.
- Monitor changes to regulations in regards to Quality systems (QMS) and Clinical Systems (GCP).
Requirements:
- Bachelor’s degree or higher
- At least ten years of experience in quality assurance or clinical research with human subjects and Quality Management systems( QMS)
- ASQ, SQA or equivalent certification preferred
- Demonstrated ability to establish and maintain relationships with clients and internal Associates
- Knowledge of appropriate regulations and guidelines, especially ISO 9001:2015, ISO 14155, 21 CFR Parts 11, 312 and 812, MedDev, EUMDR, GDPR, and 21 CFR Parts 11, 50, 54, 56 and 812.
- Proficiency with standard computing (PC or Mac) and basic software application.
- Proficiency with process development and technical writing.
- Must be able to work independently and autonomously.
- Must possess excellent verbal and written communication skills.
- Strong organizational skills with attention to detail.
- Demonstrate a high degree of personal and professional integrity.
Benefits:
- Relocation will be considered
- Extensive use of a computer keyboard
- Some travel required 15%
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