Sr. GMP Quality Specialist - Daytona Beach, FL

Fortrea•Daytona Beach, FL

14h•Onsite

About The Position

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.

Requirements

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
Bachelor’s Degree, e.g. Biology, Chemistry, Pharmacy or relevant Engineering discipline.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Responsibilities

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.