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Quality & Compliance Manager, Computer System Validation at Precision Medicine Group - ApplyBlast

Quality & Compliance Manager, Computer System Validation

Precision Medicine Group

18 days ago

2.9 on Glassdoor

Remote

Full Time

Manager

0 applicants

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About this role

The Quality & Compliance Manager, Computer System Validation oversees the quality assurance and lifecycle validation of GxP computerized systems for CRO and laboratory operations. This role partners with cross-functional teams to ensure systems remain compliant, maintain data integrity, and are inspection-ready from implementation through retirement. The position involves establishing risk-based validation practices, reviewing assurance deliverables, and supporting regulatory audits and inspections.

Responsibilities

Provide independent quality assurance oversight of GxP computerized systems throughout the system lifecycle
Review and approve validation deliverables including risk assessments, test evidence, and compliance documentation
Ensure systems maintain data integrity and comply with FDA, EU Annex 11, and ICH regulatory requirements

Skills

Qualifications

Bachelor's degree in life sciences, computer science, information systems, engineering, healthcare, or another relevant scientific or technical disciplineMaster's degree in life sciences, computer science, information systems, engineering, quality management, regulatory affairs, or related disciplineASQ Certified Quality AuditorASQ Certified Manager of Quality/Organizational ExcellenceISACA Certified Information Systems Auditor

About Precision Medicine Group

precisionmedicinegrp.com

Headquarters

Bethesda, Maryland, United States

Company Size

1001-5000 employees

Founded

2012

View Profile

Precision Medicine Group (PMG) is a consulting and solutions firm that helps pharmaceutical and life‑science companies accelerate drug development and improve patient outcomes by applying the discipline of precision medicine. PMG brings together specialized expertise in data and evidence generation, manufacturing, market access, and stakeholder engagement to unlock insights and speed commercialization. Focused on delivering measurable value, the company partners with innovators to advance development, strengthen access, and "move science closer to health."