Principal Quality Auditor, GCP
Precision Medicine Group
Google Cloud Platform
Principal Quality Auditor, GCP
Precision For Medicine
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇨🇦 Canada
Visit company websiteSalary
💰 $110,700 - $166,100 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Provide senior oversight and subject matter expertise to quality and compliance activities across clinical studies
- Support the Q&C Management team, Q&C staff, and project teams during all stages of a clinical study
- Serve as a subject matter expert for clinical project teams and represent Quality in project meetings
- Develop and implement complex quality and compliance concepts and techniques
- Support the Quality Management System including SOPs, training and CAPA
- Process and maintain documentation for controlled documents and maintain Q&C trackers, databases, metrics, and files
- Develop and administer training for employees and consultants and mentor Q&C staff
- Host client/sponsor audits and support regulatory inspections
- Coordinate and conduct assessments of potential and contracted vendors, including vendor audits
- Coordinate and conduct internal audits, investigator site audits, and trial master file audits
- Participate on computer systems validation projects and systems change control processes
- Monitor quality systems to provide feedback on compliance risks and identify opportunities for improvement
- Support proposals and bid defense meetings and perform additional tasks as required
Requirements
- 5 years of experience
- Working knowledge of GCP/ICH guidelines and FDA regulations and standards
- Audit experience conducting a variety of audit types, including internal systems, vendors, TMF and investigator site audits
- Bachelor’s degree in a science, healthcare, or related field (combination of qualifications and equivalent relevant experience may be accepted)
- Availability to travel up to 25% domestically and/or internationally
- QA certification preferred (e.g., CQA, SQA)
- CRO, Pharmaceutical and/or Medical device experience preferred
- Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO)
- Proficient in Microsoft Word, Excel, and PowerPoint
- Excellent interpersonal and problem-solving skills, effective verbal and written communication, computer skills
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality managementcomplianceauditGCPICH guidelinesFDA regulationsclinical trial systemsCAPAdocumentation managementtraining development
Soft skills
interpersonal skillsproblem-solving skillsverbal communicationwritten communicationmentoringteam collaborationorganizational skillsleadership
Certifications
CQASQA