Role OverviewVedanta Biosciences is seeking an experienced Head of Quality to lead the Quality Assurance (QA), Quality Control (QC), and Clinical Quality Assurance (CQA) functions. The ideal candidate will lead a multi-faceted team of Quality professionals and deliver phase-appropriate GXP Quality guidance for Vedanta's lead asset, VE303.
What You Will Do
The successful candidate will oversee clinical trial and product compliance globally by managing and improving existing quality systems and ensuring appropriate controls for Vedanta's in-house cGMP manufacturing capabilities and internal QC testing.
Why It Might Be a Fit
The Head of Quality will lead process validation activities, including planning and execution of Process Performance Qualification (PPQ) batches, and collaborate with a Qualified Person (QP) to ensure compliance with EU GMP requirements.
Requirements
- BS/MS in a relevant scientific discipline (e.g., Microbiology, Biochemistry)
- 15+ years of relevant professional experience
- 10+ years of experience in Quality Management with several years in a biotherapeutics manufacturing setting
- Deep knowledge of cGXP requirements
- Experience with FDA, QP, BIMO, and EMA/MHRA inspections and audits
- Experience directly supporting on-site production, including responsibility for product disposition
- Proven track record of leadership, people management, and effective interpersonal and communication skills
Benefits
- stock options
- target annual bonus
- benefits
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