QA Lead

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 ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Summary of Responsibilities:

• Works with internal teams to progress quality issues in QMS.
• Tracks timeliness of cases in QMS.
• Supports teams in creation of CAPAs.
• Maintains strong working knowledge of QMS.
• Interacts with QA Lead Manager and above as required for quality issue case progression and client notifications.
• Supports QA Lead Manager and above in pulling metric data, trending, and tracking of QI.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• 8 years in regulatory environment (experience in GXP roles).
• Strong understanding of QMS and CAPA process.
• Ability to work well within a team environment.
• Convey key details of quality issues internally.
• Communicate quality issue summary to clients where applicable.
• Knowledge of GCPs/GxPss.

Physical Demands/Work Environment:

• Tasks involve sitting in front of a terminal for many hours during the working day.
• Travel Required.

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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If, as a result of a disability, you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.