Quality Assurance Manager

Role Overview

• 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

Tech Stack

• Google Cloud Platform

Benefits

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