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. Job Purpose: The task portfolio includes Quality Event support, audit support, Quality support and consultancy generally worldwide but for the India Biostatistics and Statistical Programming teams, and for this purpose partnering with the India heads of these teams 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. Support of functional SOP updates and participation in general Quality-related initiatives 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. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™