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%

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Quality Management Systems (QMS)Clinical Systems (GCP)Quality AssuranceProcess DevelopmentTechnical WritingKey Process IndicatorsTrending and Reporting

Soft Skills

Relationship ManagementVerbal CommunicationWritten CommunicationOrganizational SkillsAttention to DetailIntegrityAutonomy

Certifications

ASQ CertificationSQA Certification