$140K — $150K
Quality Pharma Control Director needs - 5 + years of higher management/director level experience
Quality Pharma Control Director requires:
Ø BS degree in scientific field
Ø RECENT Experience from scientific GMP environments (Pharma/med device/biologics/cell therapy/gene therapy)
Ø - Commercialization experience
Ø - NO Consultants
Ø - NO job hoppy candidates
Ø Bachelor of Science in biological sciences or other relevant field of study
Ø 15 years of relevant experience of which at least 5-10 years in a Management role overseeing a laboratory environment with applicable clinical or commercial experience.
Ø Experience with environmental monitoring and aseptic processing is preferred.
Ø Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis.
Ø Understanding of quality system applications, including the training, deviations, CAPA management, etc.
Ø Experience in authoring, reviewing, and /or approving cGMP related documents (investigation, validation/qualification reports, SOPs etc.)
Ø Experience in organizing and leading teams.
Ø Experience participating in health authority inspections and/or client audits.
Ø Understand requirements pertaining to aseptic manufacture of cellular products.
Ø Strong understanding of Tech Transfer and Method Validation
Ø Ability to work effectively with clients in a contract manufacturing environment.
Ø Familiarity with the product development process for biological products is helpful.
Quality Pharma Control Director duties
Valid through: 10/2/2020