Remote QA Lead, Computer System Validation & Compliance

Precision Medicine Group; Bethesda (MD); 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

Paid time off

Job summary

Precision Medicine Group is looking for a Quality & Compliance Manager, Computer System Validation to oversee the lifecycle validation of GxP computerized systems across CRO and laboratory operations. This role partners with Quality, IT, system owners, and vendors to ensure data integrity and inspection readiness from implementation through retirement.

Responsibilities include risk-based QA oversight, validation deliverables review, compliance with 21 CFR Part 11/EU Annex 11, and supporting

Qualifications

• Bachelor's degree in life sciences, computer science, information systems, engineering, healthcare, or another relevant scientific or technical discipline.
• A minimum of six years of progressively responsible experience in Quality Assurance, computer system validation, computer software assurance, information technology quality, or related discipline within a regulated life sciences environment.
• Demonstrated experience providing independent QA oversight of GxP computerized systems throughout the system lifecycle, including risk assessment, validation planning, requirements, testing, traceability, and retirement.
• Experience reviewing and approving computer system validation or assurance documentation, such as validation plans, risk assessments, requirements specs, test plans/evidence, traceability matrices, deviations, validation reports, and change-control records.
• Regulatory requirements knowledge: FDA electronic records/signatures, EU Annex 11, ICH GCP/GLP/GCLP, data integrity principles.
• Experience with CRO/clinical research/lab operations systems (EDC, CTSM, ELN, LIMS, CDS, etc.).
• Experience with risk-based validation for SaaS/hosted software, interfaces, and lab instrument software.
• Experience supporting supplier qualification, audits, sponsor inspections, and remediation of compliance observations.
• Collaborative work with system owners, IT, Information Security, Clinical/Lab ops, QA, vendors in a matrixed org.
• Equivalence: education/training/experience covering required knowledge and abilities.

Responsibilities

• Provide independent, risk-based QA oversight of GxP computerized systems across the lifecycle.
• Review and approve validation deliverables, ensuring testing is planned, executed, and traceable.
• Ensure systems comply with electronic records, signatures, audit trails, access controls, and data retention requirements.
• Provide QA oversight for systems used in clinical research and laboratory operations.
• Oversee ongoing validated state through changes, incidents, deviations, CAPAs, and migrations.
• Support qualification/oversight of software, cloud, data, and service providers; coordinate with stakeholders.
• Develop and improve policies, templates, tools, and training for CSV and software assurance.
• Prepare for sponsor audits/reg inspections and coordinate responses to observations.
• Establish and report metrics on validation status, compliance, risks, and supplier performance.

Skills

Quality Assurance

GxP

Computer System Validation

Regulatory Compliance

Vendor Management

Education

Bachelor's degree in life sciences, computer science, information systems, engineering, healthcare

Six years of QA/CSV experience in regulated life sciences

Regulatory knowledge: FDA 21 CFR Part 11, EU Annex 11

Tools

LIMS

ELN

CDS

Job description

Precision Medicine Group is looking for a Quality & Compliance Manager, Computer System Validation to oversee the lifecycle validation of GxP computerized systems across CRO and laboratory operations. This role partners with Quality, IT, system owners, and vendors to ensure data integrity and inspection readiness from implementation through retirement.

Responsibilities include risk-based QA oversight, validation deliverables review, compliance with 21 CFR Part 11/EU Annex 11, and supporting