Remote CSV QA Lead - GxP Compliance & Validation

Precision for Medicine

United States

Remote

USD 92,000 - 120,000

Full time

39 hours ago

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Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings benefits

Paid time off

Job summary

The Quality & Compliance Manager, Computer System Validation at Precision Medicine Group oversees QA of GxP computer systems across CRO and lab operations, ensuring data integrity and inspection readiness from implementation through retirement. Partners with Quality, IT, system owners, and vendors to maintain risk-based, compliant validation lifecycle.

This role requires a Bachelor's in life sciences or IT with at least six years in QA or CV in regulated life sciences.

Qualifications

Bachelor’s degree in life sciences, computer science, information systems, engineering, or related field.
Minimum six years in QA, computer system validation, or related discipline in regulated life sciences.
Experience providing independent QA oversight of GxP systems across lifecycle.
Experience reviewing validation/assurance documentation and change-control records.
Knowledge of FDA/EU/GxP expectations and data-integrity principles.

Responsibilities

Provide independent QA oversight of GxP systems across their lifecycle.
Review validation plans, risk assessments, traceability, and test evidence.
Ensure systems are fit for use, with data integrity and audit trails.
Oversee changes, incidents, deviations, and CAPAs; ensure remediation is documented.
Support supplier qualification and audits; coordinate with stakeholders.
Develop and improve validation policies, templates, and training.