PURPOSE
Be an integral part of the Quality team by providing quality assurance oversight and leadership to operations, manufacturing, and quality control activities. Address terms of systems quality and conformance to regulations and Genezen quality policies/procedures. Help in the development of QA people and teams.
ESSENTIAL JOB FUNCTIONS / DUTIES
SPECIAL JOB REQUIREMENTS
KNOWLEDGE, SKILLS & EXPERIENCE
EDUCATION / CERTIFICATIONS / LICENSES |
Essential/Desired |
Bachelorâs degree in science or related field |
Essential |
In depth knowledge of cGMP FDA and EU regulations, and ICH guidelines |
Essential |
Familiar with regulatory guidelines for early phase clinical trials |
Essential |
Certified Quality Auditor or Certified Pharmaceutical GMP Professional
|
Desired |
ON-THE-JOB EXPERIENCE |
|
Minimum of 3-5 years of working experience in Pharma, Biologics, CGT industry in a Quality Assurance role |
Essential |
Previous experience reviewing and approving quality system reports â deviation, CAPA, change control |
Essential |
Previous experience reviewing validation protocols and reports |
Desired |
Previous experience with product/process tech transfer |
Desired |
Previous experience in the field of Gene Therapy |
Desired |
Previous experience at a fast-paced CDMO. |
Desired |
SKILLS / ABILITIES |
|
Manage multiple projects, set priorities, and work in fast-paced environment |
Essential |
Communicate confidently and effectively with management, peers, and key stakeholders |
Essential |
Demonstrate effectiveness in task completion, decision-making, empowerment of others, and problem solving |
Essential |
PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment
Movement
Lifting
Vision
Communication
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