Base: $110,000 - $150,000; bonus/equity: not speci...
On-site
Good manufacturing practices (gmp) compliance
Batch release program management
Document control and records management
GenScript Biotech Corporation is a global biotechnology group committed to being the most reliable biotech company to improve human and nature health through biotechnology
Job Summary
GenScript Biotech Corporation is a global biotechnology group committed to being the most reliable biotech company to improve human and nature health through biotechnology.
The Senior Manager, Quality Operations leads quality functions related to GMP and Phase-Appropriate compliance for clinical and marketed gene therapy products and plasmid DNA at the Hopewell manufacturing facility.
The role includes oversight of batch disposition, document control, training activities, and support for internal and external audits to ensure compliance with GMP regulations.
Matching Summary
GenScript Biotech Corporation is a global biotechnology group committed to being the most reliable biotech company to improve human and nature health through biotechnology.
Salary
Base: $110000 - $150000; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
Good Manufacturing Practices (GMP) compliance
Batch Release Program management
Document Control and Records Management
Veeva Vault Quality Docs and Training
Quality assurance for gene therapy manufacturing
Calibration report approval for GMP equipment
Nice-to-have
Excellent verbal and written communication skills
Ability to work independently and collaboratively
Analytical thinker with problem-solving skills
Adaptability to changing priorities and deadlines
Key Requirements
Bachelor’s degree in a scientific discipline
Minimum 7 years experience in Quality or related roles
At least 3 years in a CMC-focused Quality position
Experience with Veeva Vault Quality Docs and Training