Minovia Therapeutics is a clinical-stage international biotechnology company focused on treatment innovation for mitochondrial diseases. This position is recruited for our Israel site at Tirat HaCarmel, near Haifa. We have a clinical site at Sheba Tel Hashomer Hospital, and setting up additional clinical and GMP sites in the US and Europe.
Minovia is seeking to hire Head of Quality Assurance with pharmaceutical industry experience, preferably cell therapy, to join our team in establishing and expanding our global QA unit. We are looking for a candidate with excellent leadership and interpersonal skills and who thrives in an environment requiring multi-tasking and prioritization. The candidate must have significant experience in cell therapy and in requirements of GMP clean room environments. The candidate should have a willingness to adjust to the constantly changing work demands expected in a fast-paced start-up company, and a willingness to travel abroad for required global technology transfer activities.
• To manage and perform all QA responsibilities within the company, which include:
• To develop and supervise in-house GMP manufacturing methodologies and manage all related QA activities globally.
• To develop, establish, implement and maintain QA management systems, including investigations, OOS, CAPA tracking.
• To develop and maintain company SOPs globally.
• To provide support and documentation for all CMC-related regulatory requirements.
• To author, support, or audit all critical IND-enabling studies and reports.
• To maintain Document Control Management (Documentation Center and Records).
• To train employees, promoting and educating on QA principles.
• To ensure proper materials management and vendor evaluation and certification.
• To lead technology transfer to multiple sites world-wide, in the US and Europe.
• Must have experience in quality assurance in the pharmaceutical industry, manufacturing in a GMP environment, with a significant advantage for previous cellular therapy experience.
• Must have project management and managerial experience in the industry.
• Familiarity with the requirements for proper lab work documentation and ability to properly check and track the performance of the documentation.
• Fluent English.
• Organization and leadership skills, rapid learning, and thoroughness.
• Ability to meet multiple tasks and to work under pressure.
• Ability to drive a team effort.
*Software experience is irrelevant*