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About the Role
The Quality Assurance (QA) Manager leads the Quality Department, serving as the primary authority over the organization’s Quality Management System (QMS) and ensuring full compliance with clinical trial regulations and industry best practices. This role oversees quality initiatives, internal and external audit programs, incident investigations, and regulatory alignment across offices. Additionally, this role oversees the administration, continuous improvement, and software validation of the electronic Quality Management System (eQMS) and electronic Trial Master File (eTMF), with a strong understanding of the Veeva Platform. The position ensures that leadership, management and employees maintain compliance with regulatory agencies, company policies, best practices, procedures and ethical principles.
Responsibilities
- Lead and manage the Quality Department, serving as an independent and objective body to evaluate and resolve compliance and quality concerns.
- Formulate and execute strategies for continuous improvement of the QMS and compliance functions.
- Play a leadership role in the Compliance Committee and related working groups.
- Direct the creation, revision, and maintenance of departmental and company-wide policies, standard operating procedures (SOPs), internal workflows, and compliance documentation.
- Serve as the primary point of contact for senior leadership, providing reports on compliance metrics, QMS performance, and audit findings.
- Direct the operational administration, maintenance, and continuous enhancement of Veeva Vault (eQMS / eTMF).
- Oversee eQMS and eTMF software validation efforts, including testing protocols, documentation preparation, and compliance with 21 CFR Part 11 and computer system validation (CSV) standards.
- Supervise the tracking of quality metrics, non-conformances, and corrective/preventative action (CAPA) activities within Veeva Vault.
- Oversee the Internal Assessment Plan (IAP) and lead internal audits.
- Oversee external audits (regulatory and client/partner audits), serving as the lead host and coordinating responses.
- Direct investigations into incidents of non-compliance, deviation, or potential violations, producing detailed 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.
- Design, implement, and oversee an effective compliance and quality training program for all employees.
- Monitor regulatory updates (e.g., FDA regulations, GCP, 21 CFR Part 11) to ensure organizational readiness and compliance.
- Provide guidance and mentorship to QA staff, project leads, and operational teams.
- Directly supervise all members of the Quality Assurance team.
- Assign daily operational tasks, set project deadlines, provide technical guidance, and evaluate team performance.
Requirements
- 5+ years of experience in clinical research Quality Assurance and regulatory compliance, including direct supervisory/management experience.
- Preferred experience and system administration background with Veeva Vault or related software (eQMS and/or eTMF).
- Direct experience leading internal and external audits, root cause analysis, CAPA management, and computer system validation (CSV).
- Ability to collaborate with staff across multiple functional groups while ensuring that the organization’s regulatory responsibilities are being met.
- Exceptional written and verbal communication skills with the ability to interface effectively with senior executives, project leads, and regulatory authorities.
- Familiarity with Good Clinical Practice (GCP) guidelines, clinical trial data management standards, FDA regulations, and 21 CFR Part 11 requirements.
- Strong leadership, project management, and collaboration skills.
Skills
- Quality Management System (QMS)
- Clinical trial regulations
- Industry best practices
- Veeva Platform
- Veeva Vault (eQMS / eTMF)
- 21 CFR Part 11
- Computer system validation (CSV)
- Good Clinical Practice (GCP)
- Clinical trial data management
- FDA regulations
- Leadership
- Project management
- Collaboration
- Root cause analysis
- CAPA management
- Audit management
Experience Level
- 5+ years of experience in clinical research Quality Assurance and regulatory compliance
- Direct supervisory/management experience
About the Company
- Frontier Science is a contract research organization (CRO) that provides comprehensive clinical research services to pharmaceutical and biotechnology companies.
Equal Opportunity
- All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, age, or veteran status.