Job SummaryThe Quality Specialist II role is responsible for planning, conducting, and reporting audits to ensure compliance with GCP guidelines, regulatory requirements, and internal quality standards across clinical research activities.This role requires onsite presence in Johnson City, TN three days per week, with the flexibility to work remotely for the remaining two days. It is best suited for candidates within commuting distance to this location.Essential Duties and Responsibilities
Plan, schedule, and execute GCP audits (e.g., investigator sites, vendors, systems, and internal processes)
Track and follow up on audit findings and CAPAs to ensure timely resolution
Prepare detailed audit reports and issue audit certificates
Monitor and assess compliance with ICH-GCP, FDA, EMA, and sponsor-specific requirements
Support the development and implementation of quality management systems and SOPs related to central lab operations and clinical trial support
Participate and support in the identification and assessment of quality risks and advise on mitigation and controls
Performs document control activities using Veeva Vault, including but not limited to SOP creation, revision, obsolescence, and/or approvals
Support inspection readiness and participate in sponsor or regulatory inspections
Participate in the qualification and quality oversight of vendors supporting clinical trials
Provide GCP guidance to internal teams and external partners
Analyze quality metrics and trends to identify areas for improvement
Maintain up-to-date knowledge of evolving GCP regulations and industry best practices
Performs frequent assessments of the quality system for continuous improvement initiatives
Trains new hires on job specific duties and regulatory standards as deemed appropriate
Performs other related duties and tasks as necessary or as assigned by Quality Management
Education and Experience
Bachelor’s or master’s degree in life sciences, pharmacy, nursing, or a related field
5+ years quality-related roles, specializing in regulatory compliance and document management, with at least 3+ years in auditing or 3 years quality-related roles, specializing in regulatory compliance and document management, with at least 3 years in auditing with graduate degree.
Strong knowledge of ICH-GCP, FDA, EMA, and other global regulatory frameworks
Strong organizational, communication, and report-writing skills, ensuring clarity in professional communication and audit responses
Experience with electronic quality systems (e.g., Veeva, eQMS. eDMS)
Ability to work independently and collaboratively, balancing multiple projects
