Senior GCP Auditor

Quality Assurance & Compliance Southborough, Massachusetts Jacksonville, Florida Philadelphia, United States Morrisville, North Carolina Baltimore, Maryland


Description

For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.

Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.

We do things differently than large CROs and would love to have you join our Veristat team!


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.


As a Senior GCP Auditor you will...

  • Conduct various types of internal and contracted study and process / system audits per Veristat internal procedures, to ensure documentation and processes comply with regulations, GCP guidance, standards and standard operating procedures.
  • Coordinate, support and host sponsor audits.
  • Support the completion of responses to findings received from Sponsor Audits and Regulatory Inspections.
  • Assist with and provide support during regulatory inspections.
  • Coordinate and conduct on site and questionnaire vendor qualification audits.
  • Coordinate and issue annual Vendor Risk Assessments.
  • Issue audit reports in accordance with standard company format and timelines, ensuring clear communication of audit findings to project members and/or functional management.
  • Escalate significant findings to Senior QA & Compliance Management.
  • Provide guidance and support for Computer Systems Validation activities and audits.
  • Prepare quality metrics for reporting of trends to support process improvement.
  • Provide training on relevant quality management systems and/or GCP compliance.
  • Participate in Quality Improvement Initiatives.
  • Provide support to other assignments as directed by QA and Compliance.

 

Experience & Minimum Requirements:
                                                                                                            

  • Bachelor’s degree in Life Sciences or related field required.
  • 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.

 

Additional Requirements:

  • Driving/Travel requirements - Travel up to 50% (US, Canada, or International)
    • Ability to travel as needed to conduct internal and/or vendor audits
  • Physical requirements – ability to occasionally lift/move up to 25 lbs.
  • Hours/Conditions – US: 40 hour work week; Canada & UK: 37.5 hour work week
  • FLSA Classification – Exempt