Provides independent quality oversight of internal and external clinical trial activities, records, and processes to ensure compliance with FDA regulations, ICH-GCP, internal SOPs, and other applicable regulatory requirements.
Supports quality objectives across the organization and contributes to achieving departmental and company goals.
Maintains current knowledge of applicable GxP requirements and regulatory developments and communicates relevant impacts to QA leadership and stakeholders.
Supports the implementation, maintenance, and ongoing oversight of the Quality Management System (QMS).
Develops, reviews, and maintains SOPs and quality documentation to ensure compliance with applicable regulatory requirements (ICH-GCP, FDA CFR, etc.).
Provides client-facing Quality Assurance support, including development of quality documentation (e.g., SOPs, plans) and regulatory compliance guidance.
Establishes and maintains appropriate quality standards, parameters, and controls across clinical programs and quality processes.
Ensures ongoing compliance with applicable federal, state, local, and organizational regulations, guidelines, and policies.
Implements and supports Clinical Quality Assurance plans aligned with GCP standards, internal policies, and procedures.
Leads and supports inspection and audit readiness activities, including preparation, coordination, and participation in regulatory agency inspections.
Plans, conducts, and/or supports qualification, routine, and for-cause audits, and participates in the evaluation, qualification, and ongoing oversight of clinical vendors in accordance with company SOPs.
Oversees the management, tracking, and effectiveness of audit observations and CAPAs, including root cause analysis, trending, and escalation of systemic quality issues.
Evaluates quality trends and metrics to identify risks, support continuous improvement, and informs QA reporting to management.
Provides QA guidance to cross-functional teams through participation in study team meetings and interpretation of current regulatory requirements and best practices.
Conducts or supports QA review of clinical and regulatory documents, including protocols, Investigator Brochures, Clinical Study Reports, and integrated summaries, as applicable.
Supports the development and delivery of training materials and provides GCP and SOP-related training to internal stakeholders.
Collaborates with clinical teams to assess and investigate temperature excursions, deviations, and product complaints reported from clinical sites.
Participates in QA budget planning and resource forecasting activities.
Develops, monitors, and reports GCP quality metrics to support consistent quality performance across the organization.
Performs other duties and special projects as required.

Requirements

4 to 7+ years of experience in a related field required with supervisory experience a plus
Highly proficient with Office 365 (Outlook calendar, email, Excel, PowerPoint, and Word are a must)
Excellent communication skills
Acute attention to detail
Must be highly organized and able to multi-task prioritizing simultaneous tasks
Maintain confidentiality
Exercise independent judgment and discretion
Effectively work cross-functionally across the organization and externally

Benefits

health insurance
401k retirement plan
paid days off
annual performance bonus

Applicant Tracking System Keywords

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

Hard Skills & Tools

quality oversightregulatory complianceGxP requirementsQuality Management SystemSOP developmentaudit readinessroot cause analysisGCP standardsquality metricsCAPA management

Soft Skills

communication skillsattention to detailorganizational skillsmulti-taskingindependent judgmentdiscretioncross-functional collaborationclient-facing supporttraining developmentcontinuous improvement