GxP CS Validation QA Leader

Precision for Medicine

United States

Remote

USD 92,000 - 120,000

Full time

7 days ago

Be an early applicant

Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

Benefits offered by this job

Discretionary 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, Computer System Validation to oversee the quality, risk-based validation, and lifecycle assurance of GxP computerized systems across CRO and laboratory operations. You will partner with Quality, IT, system owners, and vendors to ensure systems are fit for purpose, data integrity is maintained, and inspections are ready.

The role covers validation planning, requirements, testing, change control, periodic review, and remediation

Qualifications

Bachelor’s degree in life sciences, computer science, information systems, engineering, healthcare, or another relevant scientific or technical discipline.
Six+ years of experience in QA, computer system validation, or related regulated life sciences fields.
Proven experience providing independent QA oversight of GxP systems across the system lifecycle.
Experience reviewing validation and assurance documentation and handling audits.

Responsibilities

Provide independent, risk-based QA oversight of GxP computerized systems throughout their lifecycle.
Review validation deliverables including risk assessments, validation plans, and traceability matrices.
Ensure data integrity and compliance with electronic records, signatures, audit trails, and access controls.
Support sponsor audits, regulatory inspections, and vendor engagements.