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 more than 27 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
• The estimated hiring range for this role is $94,500 - $143,000 CAD plus applicable bonus. This hiring range is specific to Canada only and will vary for other regions based upon local... market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.
• Benefits vary by location and may include:
• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans

What We Look For
• Bachelor’s degree in Life Sciences or related field required.
• 5-10 years in the R&D industry preferably in clinical research
• ASQ-CQA or similar certification strongly preferred.
• 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.
• Driving/Travel requirements – 10-25%

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.

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
Toronto ON

Salary Criteria