Sr. Manager QA Validation Computerization Systems
$120,000–$150,000 year
Remote · Saddle Brook, New Jersey, United States or United States
Saddle Brook, New Jersey, United States or United StatesRemoteFull Time$120,000–$150,000 yearSenior LevelBachelors DegreeSmall
Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Small
Job Summary
The Sr. Manager QA Validation Computerization Systems will oversee QA for computerized systems implementation, ensuring compliance with regulatory requirements. Requires a Bachelor's degree and 8+ years of experience in FDA-regulated environments.
Required Qualifications
- Bachelor’s Degree in a Scientific or Engineering discipline
- 8 + years of computerized system experience with IT compliance/validation/qualification activities
- 8 + years of experience working in an FDA-regulated, GxP-related environment
- Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance
- Comprehensive knowledge in Software Validation and Data Integrity Principles
- Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations
Desired Qualifications
- Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)
- Experience with application system validation
- Experience with writing and approving Standard Operating Procedures and Quality Standards
- Proven project management, presentation and facilitation skills
- Demonstrated results-oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs
- Solid organizational and time management skills
- Innovation and strategic compliance skills
Additional Requirements
- 10% travel required
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