Quality & Compliance Manager, Computer System Validation

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

📋 Description

• Oversee quality assurance and lifecycle validation of GxP computerized systems that support CRO and laboratory functions.

• Offer independent, risk-based Quality Assurance oversight from the initial assessment and implementation stages through to operation, periodic reviews, significant changes, and system retirement.

• Evaluate and authorize validation and assurance deliverables, which include risk assessments, validation plans, requirements, traceability documentation, test evidence, deviations, validation summary reports, and release-readiness documentation.

• Confirm that systems are suitable for their intended purpose, uphold data integrity, and adhere to procedures, client obligations, and regulatory standards.

• Supervise validated-state activities such as changes, incidents, deviations, CAPAs, upgrades, data migrations, periodic reviews, and decommissioning processes.

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

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

• Prepare for and assist with sponsor audits, regulatory inspections, and internal audits; coordinate responses to any observations made.

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

• Promote continuous improvement and escalate significant issues to Quality and business leadership.

⛳️ Requirements

• Bachelor’s degree in life sciences, computer science, information systems, engineering, healthcare, or another pertinent 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 discipline within a regulated life sciences context.

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

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

• 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.

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

• Experience in supplier qualification, conducting system or vendor audits, sponsor audits, regulatory inspections, and addressing compliance observations related to computerized systems.

• Ability to collaborate effectively 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 also be considered.

• Preferred qualifications include a Master’s degree, experience in a regulated industry, familiarity with GxP environments, team management experience, laboratory and clinical platform experience, exposure to Agile/Waterfall/hybrid methodologies, inspection and audit experience, relevant professional certifications, and knowledge of GAMP guidance and risk-based computer software assurance principles.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.