The Quality Manager at Parexel will oversee quality event support, audit support, and consultancy for Biostatistics, ensuring compliance with quality standards.
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
- Required Skills
- The job was opened specifically for the support of Biostatistics and Programming
- The task portfolio includes Quality Event support (Quality Rep role), audit support, Quality support and consultancy generally worldwide but in particular for the India Biostatistics and Statistical Programming teams, and for this purpose partnering with the India heads of these teams
- Support of functional SOP updates and participation in general Quality-related initiatives
knowledge and Experience:
- 8- 12 years’ experience in clinical research
- Demonstrated experience in Quality or Risk Management activities
- Expertise in root cause methodologies and CAPA development
- Proven leadership in mentoring teams and managing complex, multi-project accounts
- Comprehensive mastery of ICH-GCP principles and their strategic application.
- Fluency in written and oral English; additional languages an asset.
Education:
- Bachelor’s Degree required preferably in life sciences or health-related discipline or equivalent experience.
- Advanced degree (master’s degree) in a science, technology or industry-related discipline strongly preferred.
Top Skills
Biostatistics
Ich-Gcp Principles
Programming
Quality Management
Risk Management
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