Senior Quality Specialist
1 month ago
Your time here
At Parexel, Quality Specialists act as a Quality partner for GDO Biostatistics and Statistical Programming, focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise through the execution of quality SOPs to support operations, leadership and clients
- Manage the relationship with GDO Biostatistics and Statistical Programming
- Provide Quality input to audits/inspections
- Facilitate identification, investigation and remediation of Quality Issues (QIs) related to GDO Biostatistics and Statistical Programming activities
- Facilitate the Risk Evaluation process
Knowledge and Experience:
• Knowledge of ICH-GCP and clinical trial regulation
• Experience using root cause methodologies (5-whys, fishbone diagram, etc.)
• English proficiency (written and oral) • Significant industry experience in one or more areas of PQRM support and / or Quality Management
• IT literate - experience with Microsoft based applications and functional and TMF applications / languages / solutions. Able to embrace new technology and apply best practices
Skills:
• Emerging ability to lead without explicit authority
• Self-management: independent, takes initiative, proactive and organized
• Focused on quality results - attention to detail and First Time Quality
• Interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback
• Ability to develop professional, collaborative relationships both within Quality and with Operations (and clients where assigned)
• Skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues
• Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge
• Cultural awareness with the ability to think and work, globally
• Ability to travel as needed for the position
Education:
• Bachelor’s Degree or other relevant experience required. Life-science, health or industry-related discipline preferred
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