Quality & Compliance Manager – Computer System Validation

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver independent, risk-based Quality Assurance oversight for GxP computerized systems throughout their lifecycle.

• Review and authorize validation and assurance deliverables, such as risk assessments, validation plans, requirements, traceability documentation, test evidence, deviations, validation summary reports, and release-readiness documentation.

• Ensure that computerized systems are suitable for their intended use, uphold data integrity, and adhere to procedures, client commitments, and regulatory standards.

• Provide QA oversight for clinical and laboratory computerized systems, including clinical platforms, laboratory information systems, electronic laboratory notebooks, chromatography data systems, instrument software, interfaces, automated workflows, and data repositories.

• Manage the ongoing validated state by assessing changes, incidents, deviations, CAPAs, upgrades, data migrations, periodic reviews, and system decommissioning.

• Recognize and escalate compliance or data integrity risks while verifying remediation efforts.

• Assist in the qualification and continuous oversight of software, cloud, data, and computerized-system service providers.

• Collaborate with Quality, IT, Information Security, Clinical Operations, Laboratory Operations, system owners, and vendors.

• Develop and enhance policies, procedures, templates, tools, and training for computer system validation and software assurance.

• Prepare for and facilitate sponsor audits, regulatory inspections, and internal audits.

• Establish and report metrics concerning validation status, lifecycle compliance, overdue activities, deviations, CAPAs, supplier performance, and emerging risks.

• Utilize trends and lessons learned to promote continuous improvement and communicate significant issues to Quality and business leadership.

⛳️ Requirements

• Bachelor’s degree in life sciences, computer science, information systems, engineering, healthcare, or a related scientific or technical field.

• At least six years of progressively responsible experience in Quality Assurance, computer system validation, computer software assurance, information technology quality, or a related field within a regulated life sciences environment.

• Proven experience in providing independent QA oversight for GxP computerized systems throughout their lifecycle.

• Familiarity with reviewing and approving computer system validation or assurance documentation.

• 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 utilized in CRO, clinical research, or laboratory operations.

• Knowledge of risk-based validation and assurance methodologies for configurable commercial software, SaaS solutions, hosted platforms, system interfaces, laboratory instrument software, and internally configured or developed systems.

• Experience in supporting supplier qualification, system or vendor audits, sponsor audits, regulatory inspections, and the remediation of compliance observations related to computerized systems.

• Ability to work collaboratively with system owners, IT, Information Security, Clinical Operations, Laboratory Operations, Quality Assurance, vendors, and other stakeholders in a matrixed and geographically dispersed organization.

• An equivalent combination of education, professional training, and experience may fulfill the required knowledge, skills, and abilities.

🏝️ Benefits

• Discretionary annual bonus

• Health insurance

• Retirement savings benefits

• Life insurance

• Disability benefits

• Parental leave

• Paid time off for sick leave and vacation