The Laboratory Animal Management Association is seeking a Senior Specialist in Digital & Data Quality to oversee the quality of GMP computerized systems and ensure compliance with regulatory standards. The role requires collaboration with various stakeholders and emphasizes the importance of quality oversight throughout the computer system lifecycle
Job Summary
The Senior Specialist Digital and Data Quality will be responsible for the quality aspects of GMP computerized systems and the supporting infrastructure to ensure compliance with company policies, procedures and regulatory expectations.
This includes involvement in all quality-related activities for computerized systems which are required by our Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety or data integrity.
The position will work closely with stakeholders and SME’s from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.
Matching Summary
Match Score: 85
The Laboratory Animal Management Association is seeking a Senior Specialist in Digital & Data Quality to oversee the quality of GMP computerized systems and ensure compliance with regulatory standards. The role requires collaboration with various stakeholders and emphasizes the importance of quality oversight throughout the computer system lifecycle.
Salary
Base: $104,200.00 - $163,900.00; Bonus/Equity: eligible for annual bonus and long-term incentive; Benefits: medical, dental, vision healthcare and other insurance benefits, retirement benefits, 401(k), paid holidays, vacation, and compassionate and sick days
Skills & Requirements
Must-have
Computerized system lifecycle
GxP business processes
Quality oversight
Regulatory inspection support
Data integrity
ALCOA principles
Nice-to-have
Promoting GxP awareness
Continuous improvement culture
Cross-functional relationships
Coaching and developing others
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 FDA/EU/ICH regulations
Extensive knowledge of computerized system validation/compliance principles