Principal Quality Auditor, GCP
Precision For Medicine
Google Cloud Platform
Principal Quality Auditor, GCP
Precision Medicine Group
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
- Serve as a subject matter expert for clinical project teams
- Provide senior oversight and subject matter expertise to quality and compliance activities
- Support the Quality Management System including SOPs, training and CAPA
- Attend project meetings, represent Quality, review project plans and provide compliance guidance
- Process and maintain documentation for controlled documents
- Develop and administer training for employees and/or consultants
- Host client/sponsor audits and support regulatory inspections
- Coordinate and conduct assessments and audits of vendors, internal quality systems, investigator sites, and trial master files
- Participate on computer systems validation projects and systems change control process
- Monitor quality systems, maintain Q&C trackers/databases/metrics, and identify opportunities for improvement
- Support Proposals and Bid Defense meetings as needed
- 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 of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative
- Availability to travel up to 25% domestically and/or internationally
- CRO, Pharmaceutical and/or Medical device experience (preferred)
- QA certification preferred (e.g., CQA, SQA, etc.)
- Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)
- Proficient in Microsoft Word, Excel, and PowerPoint
- Excellent interpersonal, problem-solving, verbal and written communication skills
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GCPICH guidelinesFDA regulationsaudit experiencequality management systemcomputer systems validationCAPAtraining developmentdocumentation processingmetrics monitoring
Soft skills
interpersonal skillsproblem-solving skillsverbal communicationwritten communicationorganizational skillsleadership skillscompliance guidancetraining administrationclient interactionteam collaboration
Certifications
CQASQA