Job Description

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 ParexelParexel 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 RoleWe 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 ResponsibilitiesIdentify process improvement opportunities and champion their implementation across logistics and quality operationsProvide expert quality consultancy to operational groups, functional leads, and project teams while maintaining independence and objectivityMentor, train, and provide leadership direction to Quality Specialists and depot staff, fostering a culture of continuous improvement and complianceOversee quality management projects including validation review and approval processes, change request management, and quality investigationsVerify compliance with GxP guidelines, ICH-GCP standards, FDA, DEA, and local regulations across all designated operational areasSupport identification, management, and prevention of quality issues through facilitation of corrective and preventive action (CAPA) programsProvide audit and inspection support, including preparation assistance, representation during regulatory audits, and response reviewExecute QC release of medicinal products and clinical trial supplies; oversee QC activities and premise/equipment maintenance in depot and warehouse environmentsManage US state registrations, depot distribution licensing activities, and qualified officer responsibilities for Biosafety level; BSL-1 and BSL-2 operationsAssist with collection and reporting of quality metrics; remain informed about regulatory developments and share insights with the quality and operations teamsReceive approval from local QPs (Qualified Person), RPs (Responsible Pharmacist) or APs (Authorized Persons) before entering into the HQC-role Candidate ProfileYou'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 environmentThe ability to collaborate across teams, mentor staff, and communicate clearly with diverse stakeholdersA patient-focused mindset and strong attention to detail in high-stakes operationsComfort working with quality management systems, Microsoft Office applications, and general IT literacyYou have experience managing facility licenses, including state medical drug distribution Required QualificationsBachelor's degree in technology, biological science, pharmacy, or other health-related discipline, or equivalent qualification or clinical research experienceRelevant experience in Quality Management, clinical research operations, or Logistics Quality Management (LQM) supportKnowledge of GMP/GDP regulations (Good Distribution Practices), ICH-GCP standards, and clinical trial processesExperience with distribution licensing, QP, GMP and GxP auditing, and quality management systemsExperience with BSL level 1 and 2 operations and distribution of medical supplies, drugs, or devicesStrong communication, organization, and problem-solving skills with the ability to work independently and take initiativeEnglish proficiency (written and oral English) Preferred QualificationsBachelors or Master's degree in a science, technology, or industry-related disciplineTrainer's experience and expertise in developing training materials and mentoring programsExperience performing QP AuditsExperience managing distribution state licenses and licensing requirementsOversight of quality management systemsAbility to travel approximately 20-30%Experience with radiopharmaceutical operations and oversightFamiliarity with FDA, DEA, and state regulatory requirements for depot operationsExperience managing multiple complex projects simultaneously across different operational areasBenefits and CompensationHealth, Vision & Dental InsuranceTuition ReimbursementVacation/Holiday/Sick TimeFlexible Spending & Health Savings AccountsWork/Life Balance401(k) with Company matchPet InsuranceFor a complete list of benefits, please visit potential base pay range for this role is $110,000. The actual salary offered may vary within this range based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.SummaryLocation: United States - Quakertown - PennsylvaniaType: Full time

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