Senior Computer System Validation QA Manager

Precision Medicine Group; United States; Remote; USD 92,000 - 120,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings benefits

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group is seeking a Quality & Compliance Manager to oversee the validation and quality assurance of GxP computerized systems across CRO and laboratory operations. The role partners with Quality, IT, and vendors to ensure systems are fit for use, data integrity is maintained, and inspections remain ready from implementation through retirement.

Responsibilities include risk-based QA oversight, reviewing validation deliverables, and continuous improvement of software assurance

Qualifications

• Bachelor's degree in life sciences, computer science, information systems, engineering, healthcare, or related field.

Responsibilities

• Provide QA oversight of GxP computerized systems lifecycle from assessment to retirement.
• Review and approve validation deliverables and traceability artifacts.
• Ensure data integrity and regulatory compliance across electronic records, signatures, audit trails, and access controls.
• Prepare for sponsor audits, regulatory inspections, and internal audits involving computerized systems.
• Establish meaningful metrics on validation status, lifecycle compliance, and supplier performance.

Skills

QA oversight

Regulatory compliance

Risk management

Cross-functional

Documentation

Traceability

Data integrity

Quality culture

Education

Bachelor's degree in life sciences/CS/IS/engineering

Master's degree (preferred)

Tools

LIMS

ELN

CDS

EDC

CTMS

Job description

Precision Medicine Group is seeking a Quality & Compliance Manager to oversee the validation and quality assurance of GxP computerized systems across CRO and laboratory operations. The role partners with Quality, IT, and vendors to ensure systems are fit for use, data integrity is maintained, and inspections remain ready from implementation through retirement.

Responsibilities include risk-based QA oversight, reviewing validation deliverables, and continuous improvement of software assurance