Position Summary: 

The Senior Quality Auditor supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures.  Responsible for providing oversight and subject matter expertise to quality and compliance activities, supporting project teams during all stages of a clinical study.  

Essential functions of the job include but are not limited to:  

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  

Qualifications: 

Minimum Required:  

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  

Other Required: 

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  

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, computer skills 

Competencies  

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