Quality Assurance Manager

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Quality Assurance Manager

Management Amherst, NY, US

3 days ago Requisition ID: 1202

Salary: $75,000.00 Annually

Title: Quality Assurance Manager

Department: Quality Assurance

Description: 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. The QA Manager 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 the rules and regulations set by regulatory agencies, company policies, best practices, procedures and ethical principles.

Major duties and responsibilities:

Quality Department & QMS Leadership

• Lead and manage the Quality Department, serving as an independent and objective body to evaluate and resolve compliance and quality concerns within the organization.
• Formulate and execute strategies for continuous improvement of the QMS and compliance functions through internal assessments, external benchmarking, and cross-office collaboration.
• Play a leadership role in the Compliance Committee and related working groups to foster a strong culture of integrity and quality compliance.
• Direct the creation, revision, and maintenance of departmental and company-wide policies, standard operating procedures (SOPs), internal workflows, and compliance documentation specific to the areas of Quality Management.
• Serve as the primary point of contact for senior leadership, regularly 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.

Audit Management, CAPA, & Incident Response

• Oversee the Internal Assessment Plan (IAP) and lead internal audits to evaluate compliance across projects and departments.
• Oversee external audits (regulatory and client/partner audits), serving as the lead host and coordinating responses with senior management and project PIs.
• 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 following internal or external audit findings.

Training & Compliance Support

• Design, implement, and oversee an effective compliance and quality training program for all employees, covering general GCP guidelines, QMS policies, and Veeva Vault workflows.
• 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.

Reports to: Director of Project Operations

Controls over position: Recognized as an independent entity within the FDA-regulated environment, the QA Manager operates with objectivity to ensure lack of bias in clinical trial activities and QMS oversight. The QA Manager directly supervises all members of the Quality Assurance team, including Quality Assurance Specialists (such as QA Specialist I/II). The position assigns daily operational tasks, sets project deadlines, provides technical guidance, and evaluates team performance.

Required qualifications:

• 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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, age, or veteran status.