Sr. GMP Quality Specialist Daytona Beach, FL

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 worlds 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 risk-based judgement to ensure GMP QMS is executed and maintained within the Daytona Facility and global QMS.

Key Tasks will include:

• Supports the implementation of a quality management system that complies with domestic and international regulations. Ensures local compliance with the QMS requirements.

• Plays a leading role in the implementation of a quality management system that complies with domestic and international regulations. Ensures local compliance with the QMS requirements.

• Oversees and approves Quality Related Issue Resolutions Corrective / Preventive Actions (CAPA) Change Controls Vendor Management Complaint Handling and Continual Improvement

• Monitors compiles and reports on appropriate quality metrics and data trends related to the local performance of the quality management system for input into the Management Review Process; assess and report post-market surveillance data in accordance with regulatory requirements.

• Promote awareness of the applicable regulations and associated quality management system and lead the development / delivery of regulatory based training including quality management principles and risk management practices.

• Supports the annual audit program by scheduling planning leading reporting and following up of internal audits leading/supporting external vendor assessments and hosting regulatory and client inspections

• Provides regulatory approval and accountability for release (or rejection) of study related documentation (i.e. batch records methods protocols reports certificates of analysis etc.) and/or pharmaceutical material/product for use in clinical trials.

• Represents QA on key projects to ensures facilities utilities equipment and computer systems are appropriately validated/qualified; approval of key validation deliverables

• Reviews and approves controlled documents (SOPs Policies etc.) to ensure compliance with applicable regulations Covance document management procedures and other relevant quality standards

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

• Collaborates and cross-trains with GCP QA

What you will need to bring:

• 5 years of experience within a quality-related role
• 5 years of GMP experience
• Client management experience
• Excellent leadership and interpersonal skills e.g. communication decision making problem solving data analysis auditing negotiating
• Bachelors Degree e.g. Biology Chemistry Pharmacy or relevant Engineering discipline.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

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 ERGs (employee resource groups)

Pay Range: $80000 $110000 USD

Benefits: All job offers will be based on a candidates 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) and Company bonus where applicable.

Physical Demands / Work Environment:

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

Holiday and weekend work may be required as needed

Application Deadline - June 15 2026

Learn more about our EEO & Accommodations request here.