Job
Description
The Senior Quality Auditor provides support to the audit program and clinical projects to ensure compliance with regulations and Precision procedures. You will be responsible for offering oversight and subject matter expertise to quality and compliance activities, aiding project teams throughout all phases of a clinical study. Your essential job functions will include supporting the Quality Management System by managing SOPs, training, and CAPA. You will be required to process and maintain documentation for controlled documents as needed. Additionally, you will develop and conduct training for employees and consultants. Hosting client/sponsor audits, supporting regulatory inspections, coordinating and conducting assessments of vendors, including audits, conducting internal audits of quality systems, investigator site audits, and trial master file audits are all part of your responsibilities. You will also participate in computer systems validation projects and systems change control processes. Providing QA consultation and support to assigned project teams internally and externally, managing reported quality issues and associated corrective and preventive actions, monitoring quality systems, and identifying compliance risks for QA management are crucial aspects of your role. It is essential to maintain Q&C trackers, databases, metrics, and files. You must adhere to applicable regulations and standards, including local regulations (US FDA and EU), ICH guidelines, and company policies and procedures. Other tasks as required should also be handled effectively. **Qualifications:** **Minimum Required:** - 4 years of industry experience - Clinical research experience in a non-QA role (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; relevant experience may be considered - Willingness to travel up to 25% domestically and/or internationally **Preferred:** - Experience in CRO, Pharmaceutical, and/or Medical device industry - QA certification preferred (e.g., CQA, SQA, etc.) - Familiarity with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.) **Skills:** - Strong interpersonal and problem-solving skills - Effective verbal and written communication - Proficiency in computer skills **Competencies:** - Proficient in GCP/ICH guidelines, FDA regulations, and industry standards - Intermediate proficiency in Microsoft Word, Excel, and PowerPoint - Customer service-oriented - Collaborative, flexible, and detail-oriented - Ability to work independently and in a team environment - Prioritization and multitasking abilities - Results-oriented, accountable, motivated, and flexible - Consistent with Precision Values and Company Principles - Excellent verbal and written communication skills - Fluency in English language Please note that any data provided as part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please refer to our CA Privacy Notice. If you need a reasonable accommodation to complete the application process or require an alternative method for applying due to a disability, please contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.,