Senior Auditor, Quality Assurance

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.

As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.

Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

Job Summary:

The Auditor will have a solid understanding and knowledge of appropriate ICH Good Clinical Practice (GCP) guidelines, applicable clinical research regulations for the conduct of clinical research. Experience with internal quality management systems and support of regulatory inspections.

Will be responsible for building and maintaining effective working relationships with internal customers throughout the company and provide leadership throughout the Quality Assurance function. This role is highly visible in the company and may also interact with Sponsors or vendors

Duties/Responsibilities:

• Will primarily conduct audits that will impact quality across Velocity.
• Will be responsible for building and maintaining effective working relationships with internal customers throughout the company and provide leadership throughout the Quality Assurance function.
• Maintain significant knowledge of clinical research regulatory requirements and ICH GCP principles
• Plan, execute, report routine or directed GCP audits (e.g., investigator site, vendor, internal process, document) using a risk-based approach or as identified by Velocity Quality Leadership. Lead audits that are often of a more complex nature
• Lead and/or assist with audit activities including investigator site audits, key document audits, sponsor audits.
• Follow audit activities from plan through audit closure based on experience and a sound understanding of regulatory requirements related to clinical trials, including ICH Good Clinical Practice (GCP) guidance.
• Provide interpretation and consultation to Velocity on regulations, guidelines, compliance status, CAPAs, policies and procedures, SOPs, etc.
• Support (or facilitate, as needed) onsite or remotely and report outcomes of sponsor/CRO audits of Velocity sites.
• Support regulatory inspections onsite or remotely as required by Velocity Quality Leadership
• Work within the Quality function to improve quality across Velocity:
• Assist in the creation, review, revision, and management of procedural documents and auditing tools
• Identify and escalate issues, complaints, non-conformances, etc.
• Evaluate internal compliance with Velocity procedures, policies, programs, initiatives, GCP, and applicable regulations
• Provide support for CAPA process, investigations, nonconformances and inspections and external audits. May be required to lead less complex CAPA investigations as applicable.
• Employ risk identification and mitigation strategies for identified and potential compliance issues
• Assist with oversight of contract auditor assignments, as assigned
• Provide training and mentoring to QA staff as required
• Other duties as assigned

Required Skills/Abilities:

• Excellent interpersonal, communication (verbal and written), and collaboration skills when interacting with senior management, peers, sponsors/CROs and clinical research sites
• Comprehensive knowledge, understanding and experience with GCPs and (inter)national and local regulations and laws related to clinical trials and clinical research
• Work with integrity, have a commitment to quality, be flexible, and have the ability to think critically and be creative
• Recognize and manage confidential information appropriately
• Ability to work independently or as part of a team to plan, organize, prioritize, and follow up on multiple requests, tasks/objectives, and deliverables
• Ability to lead or support sponsor audits and regulatory inspections
• Must be detail-oriented yet able to maintain a “big picture” or overview of the situation, project, business, etc.
• Practical ability in applying proactive quality approaches for clinical trials
• Proficient in the use of computers and computer systems including Microsoft Office, e.g., Word, Excel, PowerPoint, Teams; experience with Excel to identify data trends, develop charts/graphs, etc. is preferred
• Ability to work with clinical study or quality electronic systems (e.g., QMS, EDC, electronic source, e-regulatory)
• Ability to travel for work related purposes (Up to 20% travel, as needed, for audits, project team meetings, client presentations and other professional meetings/conferences as needed.)

Education and Experience:

• At least 5 years of experience conducting GCP audits to include investigator site audits, internal process audits, and vendor audits.
• BS/BA in scientific or healthcare-related field from an accredited college or university
• Require a minimum of at least 5 years of experience as a GCP Auditor in clinical QA
• Conducting GCP clinical investigator site audits and vendor audits
• Employing risk identification and mitigation strategies related to identified and potential compliance issues, or
• A combination of education, training, and experience to meet the position requirements and responsibilities.
• Certification encouraged but not required (e.g., SQA RQAP-GCP, ASQ Certified Quality Auditor).

NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required.  Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change.  All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.