Quality Manager, Logistics

Parexel; Quakertown (Bucks County); On-site; USD 99,000 - 121,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel International is seeking a Quality Manager, Logistics for our Quakertown, PA site. The role ensures quality excellence and regulatory compliance across the clinical supply chain and logistics operations, driving CAPA, audits, and process improvements.

Responsibilities include collaboration with cross-functional teams, training staff, and enabling compliant, timely delivery of clinical trial supplies to sites worldwide.

Qualifications

• Bachelor's degree or equivalent in a health-related discipline or clinical research experience.
• Knowledge of GMP/GDP regulations, ICH-GCP, and clinical trial processes.
• Experience with distribution licensing, QP, GMP and GxP auditing, and quality systems.

Responsibilities

• Identify process improvements across logistics and quality operations.
• Provide expert quality consultancy to operational groups and project teams.
• Mentor and lead Quality Specialists and depot staff in continuous improvement and compliance.
• Oversee quality management projects including validation reviews, change requests, and investigations.
• Ensure compliance with GxP, FDA, DEA, and local regulations across operations.

Skills

Quality management

Regulatory compliance

Process improvement

QP Audits

On-site audits

Education

Bachelor's degree in life sciences

Tools

Microsoft Office

Job description

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 localQPs (Qualified Person), RPs (Responsible Pharmacist) or APs (Authorized Persons)beforeentering intothe 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) supporti>
• 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 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

Benefits and Compensation

• Health, Vision & Dental Insurance
• Tuition Reimbursement
• Vacation/Holiday/Sick Time
• Flexible Spending & Health Savings Accounts
• Work/Life Balance
• 401(k) with Company match
• Pet Insurance
• For a complete list of benefits, please visit www.parexel.com/us-benefits

The 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.

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 Disclaimer Parexel 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.