head of quALITY
Vedanta is pioneering the development of a new class of therapies that act by modulating the composition of the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune, infectious, and metabolic diseases in ways that are completely different from existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field. Vedanta was founded by PureTech Ventures and a team of world renowned experts in immunology and microbiology.
Position Description / Responsibilities
Vedanta is looking for a talented Head of Quality. This position will manage and continually improve on existing quality systems to assure control for Vedanta’s in house cGMP manufacturing capability. This includes expansion of existing base Quality Management System (QMS), development of documents, training of personnel, and quality oversight of Live Biotherapeutic Product (LBP) manufacturing. The position will be supported by a mix of direct reports, consultants and contractors. In addition, Vedanta uses third party vendors for analytics and final fill finish manufacturing. The Head of Quality Assurance will be responsible for QA aspects of these vendors through site audits, establishment of Quality Agreements, major deviation review, and batch disposition/release. Depending on the qualifications of the individual candidate, there may be opportunity to include responsibilities for the QC and Analytical services function. This would entail management of QC personnel responsible for external analytical testing for DS / DP release, stability, as well as product characterization.
The candidate will
- Lead the establishment of a Quality Management System (QMS) suitable to support internal cGMP manufacturing of LBP.
- Help develop, review and approve Policies and Procedures
- Assure that the training of manufacturing personnel is appropriate
- Take a leadership role in batch disposition and deviation remediation
- Conduct third party audits, and establish quality agreements
- BS/MS in a scientific discipline (e.g. Microbiology, Biochemistry), BS (15+ yrs. experience) MS (10+yrs experience)
- 7+ years’ experience in quality assurance management within a biotherapeutics setting is required
- Must have a demonstrated ability to give quality guidance, reliably hitting timelines and achieving results in a team environment.
- Should possess some technical knowledge of a number of biologics manufacturing areas such as fermentation or ultrafiltration.
- Experience in vendor management is required.