Precision Medicine Group

Principal Quality Auditor – GCP

Precision Medicine Group

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $96,500 - $144,700 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, supporting the Q&C Management team, Q&C team members, and project teams during all stages of a clinical study.
  • Serve as a subject matter expert for clinical project teams
  • Develops and implements concepts and/or techniques to achieve objectives
  • Understands Precision processes and functional SME organization to work through complex tasks independently to resolution
  • Support the Quality Management System including SOPs, training and CAPA
  • Attends project meetings, representing Quality. Reviews project plans and provides compliance guidance on complex issues independently.
  • 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
  • Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement
  • Maintains Q&C trackers, databases, metrics, and files
  • Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures
  • 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.)
  • Excellent interpersonal and problem-solving skills, effective verbal and written communication, computer skills