- Posted: over a month ago
The Auditor will have a sound understanding and knowledge of appropriate Good Clinical Practice guidelines and applicable clinical research regulations and laws for the conduct of clinical research. This individual will impact quality across Velocity, provide quality solutions to both internal (clinical sites, management) and external customers, and will be responsible for building and maintaining effective working relationships throughout the company.
This role is highly visible in the company and to Sponsors/CROs and regulatory authorities.
Position Reports To:
Senior Director, Quality
Position Qualification Requirements:
Education and Experience:
- BS/BA in scientific or healthcare-related field from an accredited college or university
- Prefer a minimum of 3-5 years of experience as a GCP Auditor in clinical QA
- 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)
- 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)
Required Physical Abilities:
- Sit or stand for long periods of time
- Travel locally and across North America locations where Velocity sites or vendors are located.
- Communicate in person, electronically, and by telephone
- Ability to lift up to 30 pounds
- Work within the Quality function to improve quality across Velocity through all aspects of quality management, e.g., audits, CAPAs, consulting, procedural document development (e.g., SOP, Work Instructions, Guides, best practices), trending reports, training, and other parts of Velocity’s quality management systems
- Provide interpretation and consultation to Velocity on regulations, guidelines, compliance status, CAPAs, policies and procedures, SOPs, etc.
- Plan, execute, report audits (e.g., vendor, internal process, investigator site, routine or directed) and follow through to audit closure based on experience and a comprehensive understanding of regulatory requirements related to clinical trials, including ICH Good Clinical Practice (GCP) guidance
- Assist in the creation, review, revision, and management of procedural documents
- Evaluate internal compliance with Velocity procedures, policies, programs, initiatives, GCP, and applicable regulations
- Prepare, review, and support CAPA process with Velocity site personnel through closure of CAPA
- Support/facilitate and report sponsor/CRO audits of Velocity sites with Principal Investigators, study leads, site director, and Velocity management.
- Support regulatory inspections onsite or remotely as required by Velocity Quality Leadership
- Identify and escalate issues, complaints, non-conformances, etc.
- Report, manage, and follow deviations, complaints, issues, non- conformances and their related CAPAs
- Employ risk identification and mitigation strategies related to identified and potential compliance issues
- Provide training and presentations to Velocity, e.g., GCP topics, quality trends, continuous improvement activities and outcomes
- Maintain Quality tracking documents; coordinate, analyze and report quality metrics
- Train new staff as required
- Assist in management of contract auditors
- Other duties as assigned
Head of Quality
Velocity Clinical Research
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