Quality Manager Jobs

About The Position

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.