As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

QA Compliance Auditor

Hybrid role located in Dallas, TX.

Job Summary:

The QA Compliance Auditor is responsible for conducting various audit activities, including internal and sponsor audits, reviewing Standard Operating Procedures (SOPs) and Quality Events, and supporting site-specific quality matters. This role involves developing and delivering training sessions for operational groups, including basic and intermediate audit activities, and providing guidance on quality and compliance issues. The Auditor also fosters relationships between QA and operational teams across different sites, offering recommendations to enhance compliance and efficiency. In addition, they manage local quality initiatives aimed at improving the effectiveness and compliance of the QA organization and ensure adherence to Regulatory Compliance and Quality Assurance responsibilities as outlined in applicable documents. This position requires a blend of technical expertise, training skills, and collaborative capabilities.

Essential Job Duties:

• Conduct work as required per audit activity, including but not limited to, performing Internal Audits, hosting Sponsor Audits, reviewing SOPs and Quality Events, support for site related quality matters.
• Development and delivery of training (to operational groups).
• Delivery of training in performance of audits (basic, intermediate audit activities).
• Provide advice and guidance on aspects of quality and compliance.
• Provide consultation to the operational team on quality issues.
• Cross-site QA and operational relationship, provide recommendations for improving compliance and/or efficiency.
• Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills].
• Manage local Quality initiatives aimed at improving compliance and/or efficiency of the local QA organization.
• Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed.
• All other duties as needed or assigned

Qualifications:

• University/college degree, preferably in a healthcare/scientific field. Specific clinical research experience may be substituted for education.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Minimum Requirements:

• 4 years of experience in regulatory environment
• GCP experience within auditing
• CRO experience
• Experienced GXP auditor.
• Able to influence QA strategy.
• Ability to communicate with groups.
• Knowledge of multiple operational areas.
• Knowledge of industry quality systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios.

Pay Range: 85,000k – 95,000k USD

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.  For more detailed information, please click here.    Application Deadline: September 20th, 2024

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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