Quality Assurance Manager
About The Position
The Quality Assurance Manager leads the Quality Department and serves as the organization’s primary authority over its Quality Management System (QMS). The role ensures compliance with clinical trial regulations, industry best practices, company policies, procedures, and ethical principles. It oversees quality initiatives, audit programs, incident investigations, and regulatory alignment across offices, while fostering an independent and objective approach to quality oversight. The manager oversees the administration, maintenance, continuous improvement, and software validation of the electronic Quality Management System (eQMS) and electronic Trial Master File (eTMF), including Veeva Vault. The role leads the development and maintenance of quality policies, standard operating procedures, workflows, and compliance documentation; monitors quality metrics and corrective and preventive action activities; and reports on QMS performance and audit findings to senior leadership. The position directs internal and external audits, investigations of potential non-compliance, and CAPA planning. It also develops and oversees employee training on quality and compliance topics, monitors regulatory changes, and provides guidance to QA staff, project leads, and operational teams. The QA Manager directly supervises the Quality Assurance team and reports to the Director of Project Operations.
Requirements
- At least 5 years of experience in clinical research Quality Assurance and regulatory compliance, including direct supervisory or management experience.
- Direct experience leading internal and external audits, root-cause analysis, CAPA management, and computer system validation.
- Ability to collaborate across functional groups while ensuring the organization meets its regulatory responsibilities.
- Exceptional written and verbal communication skills, including the ability to work effectively with senior executives, project leads, and regulatory authorities.
- Familiarity with Good Clinical Practice guidelines, clinical trial data management standards, FDA regulations, and 21 CFR Part 11 requirements.
- Strong leadership, project management, and collaboration skills.
Nice To Haves
- Experience and system administration background with Veeva Vault or related eQMS and/or eTMF software.
Responsibilities
- Lead and manage the Quality Department as an independent and objective function for evaluating and resolving quality and compliance concerns.
- Develop and execute strategies for continuous improvement of the QMS and compliance functions through internal assessments, external benchmarking, and cross-office collaboration.
- Participate in the Compliance Committee and related working groups to promote integrity and quality compliance.
- Direct the creation, revision, and maintenance of quality-related policies, SOPs, workflows, and compliance documentation.
- Serve as the primary point of contact for senior leadership and report on compliance metrics, QMS performance, and audit findings.
- Direct the administration, maintenance, and continuous enhancement of Veeva Vault eQMS and eTMF.
- Oversee eQMS and eTMF software validation, including testing protocols, documentation, and compliance with 21 CFR Part 11 and computer system validation standards.
- Supervise tracking of quality metrics, non-conformances, and CAPA activities in Veeva Vault.
- Oversee the Internal Assessment Plan and lead internal audits across projects and departments.
- Oversee external regulatory, client, and partner audits, serving as the lead host and coordinating responses with senior management and project principal investigators.
- Direct investigations into non-compliance, deviations, or potential violations and prepare written reports with root-cause analyses and recommendations.
- Work with Office Directors, Project Leads, and Department Heads to design, implement, and track timely CAPA plans following audit findings.
- Design, implement, and oversee employee quality and compliance training covering GCP, QMS policies, and Veeva Vault workflows.
- Monitor regulatory updates to support organizational readiness and compliance.
- Guide and mentor QA staff, project leads, and operational teams.
- Directly supervise Quality Assurance team members, assign daily work, set project deadlines, provide technical guidance, and evaluate performance.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
