iAM Jobs

 

• • 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.