Quality & Compliance Manager, Computer System Validation

Location: Remote, United States. Candidates must be legally authorized to work in the United States without employer sponsorship.

Salary: $91,500–$120,000 USD annually, plus eligibility for a discretionary annual bonus.

Company

hirify.global supports clinical research and laboratory operations through regulated GxP systems and quality processes.

What you will do

• Provide independent, risk-based Quality Assurance oversight of GxP computerized systems from assessment and implementation through operation, periodic review, changes, and retirement.
• Review and approve validation and assurance deliverables, including risk assessments, plans, requirements, traceability records, test evidence, deviations, summary reports, and release-readiness documentation.
• Ensure systems remain fit for intended use, protect data integrity, and comply with requirements for electronic records, signatures, audit trails, access controls, security, backup, archival, and retention.
• Oversee changes, incidents, deviations, CAPAs, upgrades, migrations, periodic reviews, and decommissioning while identifying and escalating compliance risks.
• Support qualification and oversight of software, cloud, data, and computerized-system providers in partnership with Quality, IT, Information Security, clinical and laboratory operations, system owners, and vendors.
• Prepare for audits and inspections, maintain inspection-ready records, report validation and compliance metrics, and drive continuous improvement.

Requirements

• Bachelor’s degree in life sciences, computer science, information systems, engineering, healthcare, or a related scientific or technical discipline, or an equivalent combination of education and experience.
• At least six years of progressively responsible experience in Quality Assurance, computer system validation, computer software assurance, IT quality, or a related discipline within a regulated life sciences environment.
• Demonstrated experience overseeing GxP computerized systems throughout the lifecycle, including risk assessment, validation planning, requirements, testing, traceability, release, change control, periodic review, incident management, data migration, and retirement.
• Working knowledge of FDA electronic-record and electronic-signature requirements, EU Annex 11, ICH Good Clinical Practice, Good Laboratory Practice, and data-integrity principles.
• Experience with clinical and laboratory platforms such as EDC, CTMS, eTMF, IRT/RTSM, LIMS, ELN, chromatography data systems, instrument software, interfaces, and automated workflows.
• Must be legally authorized to work in the United States without employer sponsorship.

Nice to have

• Master’s degree or professional certification in quality, auditing, regulatory affairs, or computer-system validation.
• Experience in a contract research organization, regulated laboratory, biotechnology, pharmaceutical, or medical-device organization.
• Experience across GCP, GLP, GCLP, and GMP environments, or managing geographically dispersed validation and quality teams.
• Experience with Agile, Waterfall, or hybrid development methodologies and risk-based computer software assurance.
• Experience supporting health-authority inspections and sponsor audits involving computerized systems, electronic records, data integrity, or system validation.

Culture & Benefits

• Remote work arrangement within the United States.
• Collaboration across Quality, IT, Information Security, clinical operations, laboratory operations, system owners, and external providers.
• Health insurance, retirement savings benefits, life insurance, and disability benefits.
• Parental leave and paid sick leave and vacation.
• Eligibility for a discretionary annual bonus.