Quality Control Manager
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.
It is critical that, for all our
- sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The Quality Control Manager position has a significant impact in achieving those objectives.
The Quality Manager oversees all Clinical Quality activities in Romania.
The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the Quality Managers support audits, inspections as well as Quality Control and local training activities.
Minimum required education:
Bachelor’s Degree or equivalent in relevant health care area.
Required experience and skills:
+ A minimum of 6 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. Experience in Country Operations preferred.
+ Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations.
+ Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
+ Demonstrated experience in leading
- functional teams.
+ Ideally, experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement.
+ Ideally, experience in managing audits and inspections.
+ Ideally, experience in coordinating and delivering training sessions.
+ Superior oral and written communication and leadership skills in an international environment.
+ Excellent project management, organizational and prioritization skills.
+ Excellent teamwork skills, including conflict resolution expertise and discretion.
+ Ability to analyze, interpret, and solve complex problems.
+ Ability to think strategically, objectively and with creativity and innovation.
+ Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.
Fortrea is actively seeking motivated
- 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
- 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.
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