Ref: GCP QA//MM
Mackenzie Stuart is working in close partnership with a fast-growth Clinical Research Organisation with extensive clinical trial experience and operational excellence in a wide range of therapeutic areas.
Our client is actively recruiting a GCP Auditor – US based. This individual will be responsible for conducting audits and providing quality solutions to both internal and external customers whilst building and maintaining effective working relationships throughout the company.
- Travel locally and across North America locations where sites are located as needed.
- Maintain knowledge of ICH GCP principles
- Lead/assist audit activities, inc. investigator site, key document, and sponsor audits
- Follow audit activities from plan to closure
- Support regulatory inspections onsite or remotely
- Maintain quality tracking documents
- Train new staff as required
- Provide presentations on GCP topics, quality trends, continuous improvement activities
- Assist with oversight of contract auditor assignments
- Knowledge of ICH Good Clinical Practice guidelines
- Understanding of clinical research regulations
- Minimum of 3 years’ experience as GCP Auditor in Clinical QA
- BS/BA Scientific/Healthcare related field
- Experience of risk identification and employment of mitigation strategies
- Required certification preferable; (SQA RQAP-GCP, ASQ Certified Quality Auditor)
- Excellent interpersonal communication skills
- Knowledge with GCPs and international and local regulations related to clinical trials
- Ability to work independently and as a team
- Practical ability in applying proactive quality approaches for clinical trials
- Experience with clinical study/quality electronic systems
About Mackenzie Stuart Global Executive Search & Selection:
Mackenzie Stuart is a leading executive search and selection business. From our offices in Leeds, London & Toronto we provide retained and contingency recruitment solutions across industry and have specialist recruitment consultants that work within the Oil & Gas, Mining, Infrastructure & Built Environment, Medical & Scientific, Healthcare, Education, Finance & Accountancy, Insurance, Water, Chemicals & Coatings, Ingredients & Flavours, Automation, FMCG and Logistics sectors.
Job Reference: GCP QA//MM
$80,000 - 120,000