The Senior Specialist will be responsible for the quality aspects of GMP computerized systems and the supporting infrastructure to ensure compliance with company policies and regulatory expectations
Job Summary
The Senior Specialist will be responsible for the quality aspects of GMP computerized systems and the supporting infrastructure to ensure compliance with company policies and regulatory expectations.
This position will work closely with stakeholders to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.
The role requires ensuring technologies selected meet business needs while encouraging innovation and efficiency, and providing independent quality approval of key validation documentation.
Matching Summary
The Senior Specialist will be responsible for the quality aspects of GMP computerized systems and the supporting infrastructure to ensure compliance with company policies and regulatory expectations.
Salary
$104,200.00 - $163,900.00; Bonus/Equity: Annual bonus and long-term incentive, if applicable; Benefits: Comprehensive package including medical, dental, vision, retirement, paid holidays, vacation, sick days
Skills & Requirements
Must-have
Computerized system lifecycle quality oversight
GxP compliance for IT systems
21 CFR Part 11, 210, 211, 820 knowledge
Computer System Validation (CSV) principles
Regulatory inspection support
Nice-to-have
Promote GxP awareness and continuous improvement
Business engagement and collaboration skills
Mentoring junior team members
Adaptability to changing priorities
Key Requirements
Bachelor's degree in Science, IT, Engineering or equivalent
Min 5 years of experience in regulated pharmaceutical manufacturing
At least 3 years of experience in delivering validated IT solutions
Strong understanding of pharmaceutical regulations