Senior Quality Assurance Auditor - GCP, GXP

February 26

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

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Parexel

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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.

Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Lead, Perform and Report audits for area of specialization • Manage GxP audits • Lead and coordinate internal regional and global process/system audits across regions • Report outcome and trends of audit program to the process owner, QA Senior Management • Review audit reports, responses, and other program deliverable to ensure consistent high quality • Act as QA Lead on audits program(s) • Support Serious Breaches (SB) investigations • Support auditor training and mentoring of new / less experienced auditors • Maintain QA records / systems • Optimize new and existing processes to maintain and improve quality standards • Provide local, regional, and global consultancy and interpretation on regulatory compliance • Maintain sound knowledge of Parexel policies, procedures, and guidelines

🎯 Requirements

• Minimum of 2 years’ experience in quality assurance, auditing • At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science • Ability to travel internationally for audits as required • Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national, and local regulations and laws related to clinical trials and other clinical research • Ability to rapidly learn, understand and apply applicable Parexel and client procedures • Client focused approach to work • Excellent interpersonal, verbal, and written communication skills • Ability to mentor / train auditors and other personnel • A flexible attitude to work assignments and new learning • Ability to diplomatically address sensitive issues confidentially and professionally • Auditors must be detail oriented, good at decision making, able to maintain a ‘big picture’ / overview on the project / business

🏖️ Benefits

• 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