Quality & Compliance Manager, Computer System Validation
New
P
Precision for MedicineLife sciences
Remote, United StatesFull-TimeManager
Salary$91,500 — $120,000 USD
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Job Details
- Experience
- A minimum of six years of progressively responsible experience
- Required Skills
- Quality Assurance
Requirements
- Bachelor’s degree in life sciences, computer science, information systems, engineering, healthcare, or another relevant scientific or technical discipline, or an equivalent combination of education, training, 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 providing independent QA oversight of GxP computerized systems throughout the system lifecycle.
- Experience reviewing and approving computer system validation or assurance documentation, including validation plans, risk assessments, requirements, test evidence, traceability matrices, deviations, summary reports, and change-control records.
- 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 supporting computerized systems used in CRO, clinical research, or laboratory operations.
- Experience with risk-based validation and assurance for configurable commercial software, SaaS, hosted platforms, system interfaces, laboratory instrument software, and internally configured or developed solutions.
- Experience supporting supplier qualification, system or vendor audits, sponsor audits, regulatory inspections, and remediation of computerized-system compliance observations.
- Experience collaborating with system owners, IT, Information Security, Clinical Operations, Laboratory Operations, QA, vendors, and other stakeholders.
- Preferred: experience in a CRO, regulated laboratory, biotechnology, pharmaceutical, or medical-device organization and across GCP, GLP, GCLP, or GMP environments.
- Preferred: experience with clinical and laboratory platforms, Agile, Waterfall, or hybrid development methodologies, or relevant quality, auditing, or computer-system validation certification.
Responsibilities
- Provide independent, risk-based Quality Assurance oversight of GxP computerized systems throughout the system lifecycle.
- Review and approve validation and assurance deliverables, including risk assessments, plans, requirements, traceability documentation, test evidence, deviations, and summary reports.
- Ensure computerized systems are fit for intended use, maintain data integrity, and comply with applicable procedures, client commitments, and regulatory requirements.
- Evaluate changes, incidents, deviations, CAPAs, upgrades, data migrations, periodic reviews, and decommissioning activities to oversee the validated state.
- Support qualification and ongoing oversight of software, cloud, data, and computerized-system service providers.
- Partner with Quality, IT, Information Security, clinical and laboratory operations, system owners, and vendors to establish and maintain controls.
- Develop and improve policies, procedures, templates, tools, and training for computer system validation and computer software assurance.
- Prepare for and support sponsor audits, regulatory inspections, and internal audits involving computerized systems.
- Establish and report metrics for validation status, lifecycle compliance, overdue activities, deviations, CAPAs, supplier performance, and emerging risks.
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