Job Title: QA Lead
Location: Available in 3 locations
Category: Regulatory/Compliance
Job ID: 25660
Company Overview:
Fortrea is a global contract research organization (CRO) specializing in clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in around 100 countries, Fortrea is committed to transforming the development of drugs and medical devices for partners and patients globally.
Job Overview:
As a QA Lead, you will be responsible for ensuring quality standards are met within the Quality Management System (QMS). You will work closely with internal teams, track the progression of quality issues, and assist in the creation and management of Corrective and Preventive Actions (CAPAs). This position is key to maintaining high-quality standards and ensuring compliance with regulatory requirements.
Key Responsibilities:
Quality Management System (QMS):
Work with internal teams to progress quality issues in the QMS.
Track timeliness and progress of cases within the QMS system.
Support teams in the creation and implementation of CAPAs.
Quality Metrics and Tracking:
Assist in the collection and reporting of quality metrics data.
Perform trending and tracking of Quality Issues (QI) to ensure proper resolution.
Collaboration with Senior Leaders:
Interact with QA Lead Manager and above to ensure quality issue progression.
Provide notifications to clients regarding quality issues where applicable.
Communication and Reporting:
Communicate the summary of quality issues both internally and to clients as necessary.
Qualifications:
Education:
A minimum of a bachelor’s degree in Life Sciences (or equivalent experience).
Experience:
8+ years of experience in a regulatory environment, specifically in GXP roles.
Strong understanding of QMS and the CAPA process.
Familiarity with GCPs/GxP standards is essential.
Skills:
Strong communication skills, both written and verbal.
Ability to work effectively within a team and ensure the progression of quality issues.
Proficient in quality management processes and tracking.
Physical Demands/Work Environment:
This position may involve sitting for extended periods at a terminal and occasional travel as required.
Fortrea’s Culture:
Fortrea values creativity, problem-solving, and a collaborative approach. Their Fortrea FOUR culture promotes working Forward Together, Owning It, Upholding Integrity, and Respecting People. Joining the Fortrea team means contributing to global health progress and having the opportunity for personal and professional growth.
Equal Opportunity Employer:
Fortrea is an equal opportunity employer committed to fostering diversity and inclusion in the workplace. They do not discriminate based on race, religion, gender, disability, or any other legally protected characteristic.
This role offers an excellent opportunity for experienced quality professionals to join a global leader in clinical development. Let me know if you need further details or are interested in applying!
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