Job Description:
Senior GCP Auditor
The Senior GCP (Good Clinical Practices) Auditor is responsible for execution of the Audit Plan
at Veristat. S/he will plan, conduct, report and follow up on all types of GCP audits, including
internal audits, contracted audits and vendor audits. The Senior GCP Auditor will also provide
support during sponsor audits and regulatory inspections and will support all relevant activities
associated with Veristat’s Quality Management System.
What we do
For 30 years, Veristat has built a reputation as global experts in clinical development.
- 760+ Rare Disease Clinical Trials supported
- 160+ Marketing Applications supported
- In 2022 we supported 8 marketing application that received regulatory approval
- Learn more about our core values here!
What we offer
- A stimulating role in an international and dynamic work environment
- Continuous development and training opportunities
- Office or Home-Based working
- Rewards for outstanding accomplishments
What we look for
- • 5+ years of relevant GCP auditing experience in a FDA Environment such as pharmaceutical, biotech or CRO company or similar environment required.
- • Knowledgeable in relevant regulations and guidelines including 21CFR-Part11 and GCP.
- • Fluent in Microsoft Project, Outlook, Word, Excel, and PowerPoint.
- • Prior experience with electronic Quality Management Systems preferred.
Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.
Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Top Skills
What We Do
Veristat is the science-first full-service drug and biologic CRO and consultancy that integrates strategic planning, regulatory expertise, and clinical trial execution to rapidly advance the most complex or novel therapies.
At Veristat, we collaborate with clients to support the rapid delivery of life-changing therapies, helping them make sound decisions amidst uncertainties. Our scientific experts design and conduct the global activities required for any clinical, regulatory, or commercialization program comprehensively and efficiently.
With our focus on novel drug development and nearly 30 years of experience, our versatile approach and bold scientific thinking make the impossible possible. Depend on our game-changing expertise and reliable execution for fast results and positive impact to support your biologics and drugs to treat rare cancers, CNS/Neurological disorders, Endocrine/metabolic disorders, and infectious diseases.
We are…Bold. Scientific. Versatile. Veristat.
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Veristat has recently been made aware that unknown third parties that have no connection to Veristat are generating fake Veristat job postings, interviews, and even fake employment offers via emails, websites, and various social media platforms, seemingly for the purpose of fraudulently obtaining personal information from legitimate job candidates. All legitimate correspondence from Veristat will originate from our applicant tracking system (Jobvite) or an @veristat.com email address. If you have received outreach from someone claiming to be a member of our team please search our official LinkedIn company page (https://www.linkedin.com/company/veristat-llc), where all members of our authorized recruiting team can be identified, or contact us directly at [email protected]. Be vigilant
