[Hiring] Quality Operations Manager @Evolution Research Group

Role Description

The Quality Operations Manager reports to Vice President (VP) Quality Operations and is responsible for supporting and implementing quality operations initiatives to support the company’s quality management systems. At the request of Sr. Quality management, may be required to collaborate directly with:

• Project Management
• Regulatory
• Monitoring
• Information Technology/Clinical Systems
• Data Management
• Biostatistics/Programming
• Other operational staff

Essential duties include:

• Review study documents and provide feedback on protocols, Informed Consent Form templates, study plans, CAPAs, and others as necessary for compliance evaluation.
• Provide support with content for Quality Operations newsletters to CRO operational staff.
• Create quality metrics trackers to support CRO quality initiatives.
• Support Quality Operations management with sponsor audits, including preparation, interviews, and attendance during audit calls/meetings.
• Prepare and support internal eTMF audits.
• Support internal functional area system audits, including audit plans and document retrieval.
• Provide support and direct managerial duties for the Quality Operations Associate in training related to quality operation initiatives.
• Perform audits of clinical sites and/or clinical third-party vendors.
• Support VP Quality Operations and senior operations staff with FDA Inspections.
• Maintain an up-to-date understanding of regulatory compliance activities.
• Support quality initiatives as outlined in the company Quality Management Plan.
• Maintain a high level of knowledge of protocols, study plans, and other applicable study documents.
• Support the facilitation and management of vendor audits.
• Maintain good working knowledge of Clinical Research procedures and guidelines.

Qualifications

• Bachelor’s degree, preferably in a scientific/healthcare field.
• Minimum 5-7 years of experience in a related area.
• Knowledge of FDA regulatory requirements is required.
• Experience as a GCP focused clinical QA Auditor is preferred.
• Familiar with a variety of concepts, practices, and procedures in clinical research.
• Strong writing, presentation, and communication skills.
• Ability to handle multiple tasks simultaneously with strong organizational skills.
• Ability to facilitate a teamwork philosophy.

Requirements

• Ability to enter data accurately, including experience with Microsoft Office.
• Ability to work effectively and efficiently handling multiple tasks simultaneously.
• Strong interpersonal skills.
• Exceptional attention to detail.
• Excellent organizational skills.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job:

• Work in a home environment where the noise level is usually controlled by the employee.
• Travel environment where the noise level is usually moderate to high.
• Subject to many interruptions and pressure due to deadline requirements.
• Handling multiple tasks simultaneously while performing assigned duties.