Quality Manager, Logistics

About this role

When our values align, there's no limit to what we can achieve.   At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®.

About the Role 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.

Key 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 

Candidate Profile You'll thrive in this role if you bring: • Strengths in quality management, regulatory compliance, and process improvement, including oversight of quality management systems. • Experience performing QP Audits, on-site audits, conducted to evaluate whether a site complies with GMP standards. • Experience working in clinical research, healthcare, logistics, or a regulated environment • The ability to collaborate across teams, mentor staff, and communicate clearly with diverse stakeholders • A patient-focused mindset and strong attention to detail in high-stakes operations • Comfort working with quality management systems, Microsoft Office applications, and general IT literacy • You have experience managing facility licenses, including state medical drug distribution   •

Required Qualifications • 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) 

Preferred Qualifications • 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 rad

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