Quality Management System Lead

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Support the execution of Parexel Quality's strategy and Parexel's QMS. • Support execution of the strategic and tactical goals of QMSO for the key QMS elements. • Work to continuously improve Parexel’s QMS. • Maintain a familiarity with Parexel QMS-related systems. • Provide coaching, mentoring and constructive feedback to QMSO staff as required. • Manage projects and initiatives as assigned, including participants, reporting and escalations as needed. • Support management of the QMSO budget. • Support Corporate Quality in the attendance, preparation for and follow up of internal/external audits and inspections. • Work with Corporate Quality to develop and/or update quality/process documents, tools, and templates. • Provide technical knowledge and oversight and serve as an escalation point where appropriate. • Maintain a positive, results oriented work environment. • Present QMS to clients, auditors and regulatory inspectors. • Lead cross functional improvements projects as required.

🎯 Requirements

• 5 to 8 years work experience • Substantial experience in Clinical Research field (pharmaceutical industry or CRO) or other pertinent experience in the areas of QMS support required • Knowledge of GxP compliance as required • Relevant experience in Quality Management Technology / Business Operations experience, as appropriate, preferred • Leadership and/or project management experience preferred • Training experience required • Substantial experience working in a global environment. • Bachelor’s Degree or other relevant experience required. • Life-science or other health-related discipline preferred. • Master’s Degree in a science, technology or industry-related disciple preferred.

🏖️ Benefits

• Health insurance • Professional development opportunities • Paid time off