Quality Manager at Parexel

, , India -

Full Time

Start Date

Immediate

Expiry Date

19 Apr, 26

Salary

0.0

Posted On

19 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Clinical Research, Risk Management, Root Cause Methodologies, CAPA Development, Leadership, Mentoring, ICH-GCP Principles, SOP Updates, Quality Support, Consultancy, Audit Support, Biostatistics, Statistical Programming, Empathy, Communication

Industry

Pharmaceutical Manufacturing

Description

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. 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.™

Responsibilities

The Quality Manager will support Quality Event activities, audit support, and general Quality-related initiatives, particularly for the India Biostatistics and Statistical Programming teams. This role involves partnering with team heads and ensuring compliance with quality standards.