Quality & Compliance Lead, Clinical Logistics

Parexel; Quakertown (Bucks County); On-site; USD 66,000 - 110,000; Full time

Benefits offered by this job

Health Insurance

Vision Insurance

Dental Insurance

Tuition Reimbursement

Vacation Time

401(k) Match

Pet Insurance

Job summary

Parexel in Quakertown, PA is seeking a Quality Manager, Logistics to lead quality and regulatory compliance across the clinical supply chain. This onsite role drives GMP/GDP adherence, supports audits, CAPA, and continuous improvement across depot and warehouse operations.

You will mentor staff, collaborate with cross‑functional teams and ensure timely, compliant delivery of clinical trial supplies while advancing quality programs and regulatory readiness.

Qualifications

• Bachelor's degree in technology, biological science, pharmacy, or other health-related discipline, or equivalent qualification or clinical research experience.
• Experience in Quality Management, clinical research operations, or Logistics Quality Management support.
• Knowledge of GMP/GDP, ICH-GCP, 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.

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 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.

Skills

Quality management

Regulatory compliance

Process improvement

Mentoring staff

Cross-functional collaboration

Attention to detail

English proficiency

Education

Bachelor's degree in health sciences or related field

Tools

Microsoft Office

Quality Management System

Job description

Parexel in Quakertown, PA is seeking a Quality Manager, Logistics to lead quality and regulatory compliance across the clinical supply chain. This onsite role drives GMP/GDP adherence, supports audits, CAPA, and continuous improvement across depot and warehouse operations.

You will mentor staff, collaborate with cross‑functional teams and ensure timely, compliant delivery of clinical trial supplies while advancing quality programs and regulatory readiness.