Quality & Compliance Lead — Computer System Validation

Precision for Medicine; Houston (TX); 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 lifecycle validation of GxP computerized systems across CRO and laboratory operations. You will partner with Quality, IT, system owners, and vendors to ensure data integrity and inspection readiness from implementation through retirement.

The role emphasizes independent QA oversight, risk-based validation, and continuous improvement across clinical and laboratory environments, with a focus on regulatory compliance

Qualifications

• Bachelor’s degree in life sciences, computer science, information systems, engineering, healthcare, or another relevant scientific or technical discipline.
• Six years of progressively responsible experience in QA, computer system validation, or related discipline within a regulated life sciences environment.
• Experience providing independent QA oversight of GxP computerized systems throughout the lifecycle.
• Experience reviewing and approving computer system validation or assurance documentation.
• Working knowledge of FDA/electronic records and signatures, EU Annex 11, ICH/GCP, GLP, and data integrity principles.
• Experience with CRO, clinical research, or laboratory operations environments.

Responsibilities

• Provide independent, risk-based QA oversight of GxP systems throughout their lifecycle.
• Review and approve validation and assurance deliverables with traceability and evidence.
• Ensure systems are fit for use, with data integrity and regulatory compliance.
• Provide QA oversight for clinical and laboratory platforms and data repositories.
• Oversee changes, incidents, deviations, CAPAs, and data migrations.
• Support qualification of software, cloud, data, and service providers.
• Develop and improve validation and assurance policies, templates, and training.
• Prepare for sponsor audits, regulatory inspections, and internal audits.
• Establish metrics for validation status and emerging risks; drive continuous improvement.

Skills

QA oversight

GxP systems

Risk assessment

Validation planning

Audit readiness

Regulatory compliance

Documentation practices

Education

Bachelor’s in life sciences/engineering/CS or related

Master’s degree (preferred)

Tools

LIMS

ELN

CDS

EDC

CTMS

eTMF

Job description

Precision Medicine Group is seeking a Quality & Compliance Manager to oversee the lifecycle validation of GxP computerized systems across CRO and laboratory operations. You will partner with Quality, IT, system owners, and vendors to ensure data integrity and inspection readiness from implementation through retirement.

The role emphasizes independent QA oversight, risk-based validation, and continuous improvement across clinical and laboratory environments, with a focus on regulatory compliance