Quality Manager, Logistics

Parexel•Quakertown, PA

40d•$110,000•Onsite

About The Position

We are seeking a Quality Manager, Logistics to join our team onsite out of our Quakertown, PA location. As a Quality Manager, Logistics, you will drive quality excellence and operational compliance across our clinical supply chain and logistics operations. This position plays a key role in ensuring regulatory adherence, maintaining Good Manufacturing Practices GMP/ Good Clinical Practices GDP standards, and supporting the safe and timely delivery of clinical trial supplies to research sites worldwide. You'll collaborate with cross-functional teams, champion process improvements, and contribute to supply chain operations from planning through closeout. You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through quality assurance, process optimization, and regulatory compliance. With diverse teams and continuous learning opportunities, the Quality Manager, Logistics can explore career paths and expand skills across clinical research operations and quality management.

Requirements

Bachelor's degree in technology, biological science, pharmacy, or other health-related discipline, or equivalent qualification or clinical research experience
Relevant experience in Quality Management, clinical research operations, or Logistics Quality Management (LQM) support
Knowledge of GMP/GDP regulations (Good Distribution Practices), ICH-GCP standards, and clinical trial processes
Experience with distribution licensing, QP, GMP and GxP auditing, and quality management systems
Experience with BSL level 1 and 2 operations and distribution of medical supplies, drugs, or devices
Strong communication, organization, and problem-solving skills with the ability to work independently and take initiative
English proficiency (written and oral English)

Nice To Haves

Bachelors or Master's degree in a science, technology, or industry-related discipline
Trainer's experience and expertise in developing training materials and mentoring programs
Experience performing QP Audits
Experience managing distribution state licenses and licensing requirements
Oversight of quality management systems
Ability to travel approximately 20-30%
Experience with radiopharmaceutical operations and oversight
Familiarity with FDA, DEA, and state regulatory requirements for depot operations
Experience managing multiple complex projects simultaneously across different operational areas

Responsibilities

Identify process improvement opportunities and champion their implementation across logistics and quality operations
Provide expert quality consultancy to operational groups, functional leads, and project teams while maintaining independence and objectivity
Mentor, train, and provide leadership direction to Quality Specialists and depot staff, fostering a culture of continuous improvement and compliance
Oversee quality management projects including validation review and approval processes, change request management, and quality investigations
Verify compliance with GxP guidelines, ICH-GCP standards, FDA, DEA, and local regulations across all designated operational areas
Support identification, management, and prevention of quality issues through facilitation of corrective and preventive action (CAPA) programs
Provide audit and inspection support, including preparation assistance, representation during regulatory audits, and response review
Execute QC release of medicinal products and clinical trial supplies; oversee QC activities and premise/equipment maintenance in depot and warehouse environments
Manage US state registrations, depot distribution licensing activities, and qualified officer responsibilities for Biosafety level; BSL-1 and BSL-2 operations
Assist with collection and reporting of quality metrics; remain informed about regulatory developments and share insights with the quality and operations teams
Receive approval from local QPs (Qualified Person), RPs (Responsible Pharmacist) or APs (Authorized Persons) before entering into the HQC-role