Sr. GMP Quality Specialist

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.

Senior GMP Quality Specialist

As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US.

We are currently seeking a Sr. GMP Quality Specialist, to lead and support our Clinical Pharmacology Start-up team in initiating Early Phase clinical trials for our clients with maximum speed and efficiency.

This is a full-time, office-based position in Daytona Beach, FL

If you join us, you will work with some of the world´s leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug.

This role involves leading and supporting the implementation of a quality management system (QMS) that meets both domestic and international regulations. Key responsibilities include ensuring local compliance with QMS requirements, overseeing and approving various quality-related issue resolutions and improvement actions, and managing vendor relationships and complaint handling. The role also involves monitoring and reporting on quality metrics, promoting regulatory awareness, and leading regulatory training.

Additionally, the role supports the annual audit program by scheduling and leading internal audits, managing external vendor assessments, and handling regulatory inspections. The position requires approval of documentation related to clinical trials and oversight of validation/qualification processes for facilities and systems. It includes reviewing and approving controlled documents to ensure regulatory compliance and adherence to quality standards. Other duties may be assigned by management.

What You Will Do

You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

YOU NEED TO BRING…

• 5-8 years of experience within a quality-related role
• 5-8 years of GMP experience
• Client management experience
• Excellent leadership and interpersonal skills, e.g. communication, decision making, problem solving, data analysis, auditing, negotiating
• Bachelor’s Degree
  
  
  

The important thing for us is you are comfortable working in an environment that is:

• Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
• Changing priorities constantly asking you to prioritize and adapt on the spot.
• Teamwork and people skills are essential for the study to run smoothly.
• Technology based. We collect our data directly into an electronic environment.
  
  
  

What do you get?

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
• 401(K)
• Flexible Time Off
• Employee recognition awards
• Multiple ERG’s (employee resource groups)
  
  
  

Pay Range: 80,000k – 110,000k 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:

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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