Senior Quality Auditor

Summary

Join Precision Medicine Group as a Senior Quality Auditor and contribute to a robust audit program and clinical projects. Support the Quality Management System, process documentation, and develop employee training. Conduct various audits (client/sponsor, vendor, internal, investigator site, trial master file) and participate in computer systems validation. Provide QA consultation to project teams, manage quality issues, and monitor compliance risks. Maintain Q&C trackers and databases, adhering to regulations (FDA, EU, ICH). This role requires collaboration, problem-solving, and attention to detail.

Requirements

• 4 years industry experience
• Clinical research experience in non-QA role considered (e.g., clinical research associate experience)
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards
• Bachelor’s degree in a science, healthcare, or related field of study; c ombination of qualifications and equivalent relevant experience may be accepted as an alternative
• Availability to travel up to 25% domestically and/or internationally

Responsibilities

• 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
• 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
• Additional tasks as required

Preferred Qualifications

• 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.)
• Excellent interpersonal and problem-solving skills, effective verbal and written communication, compute r skills
• Strong knowledge of GCP/ICH guidelines and FDA regulations and industry standards
• Intermediate proficiency in Microsoft Word, Excel, and PowerPoint
• 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
• Ability to prioritize work and handle multiple and/or competing assignments
• Results oriented, accountable, motivated and flexible
• Demonstrates values and a work ethic consistent with Precision Values and Company Principles
• Excellent verbal and written communications skills
• Fluent in English language and for non English speaking countries, the local language of country where position is based

Benefits

• Health insurance
• Retirement savings benefits
• Life insurance
• Disability benefits
• Parental leave
• Paid time off for sick leave and vacation
• Discretionary annual bonus