Senior Principal Quality Auditor (Remote)
Company: Precision For Medicine | Spain
Precision for Medicine is hiring a Senior/Principal Quality Auditor to join our team. Candidates can be based in either the UK, Spain, Hungary, Poland, Romania, Serbia, or Slovakia.
Position Summary
The Senior/Principal Quality Auditor supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures.
Essential Functions
Support the Quality Management System including SOPs, training, and CAPA.
Process and maintain documentation for controlled documents as required.
Develop and administer training for employees and/or consultants.
Host client/sponsor audits and support regulatory inspections.
Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted.
Coordinate and conduct internal audits of quality systems.
Coordinate and conduct investigator site audits.
Coordinate and conduct trial master file audits.
Participate on computer systems validation projects and systems change control process.
Provide QA consultation and support to assigned project teams internally and externally.
Support and manage reported quality issues and any associated corrective and preventive actions.
Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement.
Maintain Q&C trackers, databases, metrics, and files.
Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH, ISO, and company policies and procedures.
Qualifications
Minimum Required:
Requires two to five years of applicable experience or equivalent combination of education and experience.
Clinical research experience in a non-QA role considered (e.g., clinical research associate experience).
Working knowledge of GCP/ICH guidelines and FDA regulations and standards.
Hands-on experience leading clinical site audits.
Other Required:
Bachelor's degree in a science, healthcare, or related field of study.
Availability to travel up to 50% domestically and/or internationally.
Preferred:
CRO, Pharmaceutical, and/or Medical device experience.
QA certification preferred (e.g., CQA, SQA, etc.).
Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.).
Skills
Excellent interpersonal and problem-solving skills, effective verbal and written communication, and computer skills.
Strong knowledge of GCP/ICH guidelines and FDA regulations and industry standards.
Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar database.
Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and a keen attention to detail.
Ability to work independently and in a team environment.
Ability to work with cross-functional groups and management under challenging situations.
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