Senior Quality Assurance Auditor

September 15

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Parexel

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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). • Arrange meetings with client and other key stakeholders as required. • Support Serious Breaches (SB) investigations and help oversee the project teams. • 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.

Requirements

• Minimum of 2 years’ experience in quality assurance, auditing, including sound experience of applicable GxP 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 such as technology, third party supplier management. • 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, including the ability to present at conferences, meetings, and training sessions. • Ability to mentor / train auditors and other personnel. • A flexible attitude to work assignments and new learning and the ability to adjust to changing priorities and unforeseen events. • 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. • Ability to follow up on multiple tasks and projects, and to handle confidential information diplomatically.

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