Quality Manager, Clinical Logistics & Compliance

Parexel International; 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

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.