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. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

• Follow applicable departmental Standard Operating Procedures and Work Instructions

• Complete required training according to required timelines.

• Audits System Life Cycle (SLC) activities and documentation.

• Plan, conduct, and lead global internal facility, system, and process audits.

• Plan, conduct, and lead external audits of vendors and suppliers.

• Participates in client and regulatory visits as the subject matter expert in the field of computerized systems and technology compliance

• Author and review controlled documents including but not limited to SOPs and policies

• Advises internal business, IT, and QA partners on systems and technology compliance

• Leads and actively contributes to process and continuous improvement projects

• Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed.

• Other duties as assigned by management.

• And all other duties as needed or assigned.

Experience (Minimum Required):

• 3 to 5 years in regulatory environment (system compliance experience).

• Must have a sound understanding of standard computer system development life cycles to provide necessary guidance to both information technology and operational personnel.

• Thorough knowledge and understanding of GxP and computerized systems regulations and regulatory guidelines.

• Experience applying regulations in at least one GxP discipline and computerized systems standards to the conduct of drug development.

• Ability to confidently interact with clients and regulatory personnel.

• Ability to conduct effective training.

• Ability to effectively negotiate ideas and suggestions.

• Strong analytical, organizational, and interpersonal skills

Preferred Qualifications Include:

• A minimum of a bachelor's degree in Life Sciences preferred (or equivalent Life Science experience).

• The Drug Development Competencies define the behaviors necessary for the organization to achieve business outcomes. Please refer to the Drug Development Competencies for more information about company-wide expectations for all employees.

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.

For more information about how we collect and store your personal data, please see our Privacy Statement.