JOB SUMMARY

The Quality & Compliance Manager, Computer System Validation manages the quality oversight and lifecycle validation of GxP computerized systems supporting CRO and laboratory operations. The role partners with Quality, IT, system owners, operational teams, and external providers to ensure systems are fit for intended use, maintain data integrity, and remain compliant and inspection-ready from implementation through retirement. The Manager establishes consistent, risk-based computer system assurance practices and drives continuous improvement across clinical and laboratory environments.

MAIN DUTIES & RESPONSIBILITIES

• Provide independent, risk-based Quality Assurance oversight of GxP computerized systems throughout the system lifecycle, from initial assessment and implementation through operation, periodic review, significant change, and retirement.
• Review and approve applicable validation and assurance deliverables, including system risk assessments, validation plans, requirements, traceability documentation, test evidence, deviations, validation summary reports, and release-readiness documentation. Confirm that testing is appropriately planned, executed, documented, and traceable without assuming responsibility for business-owned testing or project execution.
• Ensure computerized systems are fit for intended use, maintain data integrity, and comply with applicable internal procedures, client commitments, and regulatory requirements, including requirements relevant to electronic records, electronic signatures, audit trails, access controls, security, backup, archival, and record retention.
• Provide QA oversight for computerized systems supporting clinical research and laboratory activities, including clinical platforms, laboratory information systems, electronic laboratory notebooks, chromatography data systems, instrument software, interfaces, automated workflows, and associated data repositories, as applicable to the role’s scope.
• Oversee the ongoing validated state of computerized systems by evaluating changes, incidents, deviations, corrective and preventive actions, upgrades, data migrations, periodic reviews, and decommissioning activities. Identify and escalate compliance or data-integrity risks and verify that appropriate remediation is completed and documented
• Support the qualification and ongoing oversight of software, cloud, data, and computerized-system service providers. Partner with Quality, IT, Information Security, Clinical Operations, Laboratory Operations, system owners, and vendors to clarify accountabilities and ensure that adequate controls are established and maintained.
• Develop, maintain, and improve policies, procedures, templates, tools, and training for computer system validation and computer software assurance. Promote consistent, scalable, and risk-based practices across CRO and laboratory environments.
• Prepare for and support sponsor audits, regulatory inspections, and internal audits involving computerized systems. Ensure validation records are complete, accurate, readily retrievable, and inspection-ready, and coordinate responses to observations within the role’s area of responsibility.
• Establish and report meaningful metrics for validation status, lifecycle compliance, overdue activities, deviations, CAPAs, supplier performance, and emerging risks. Use trends and lessons learned to drive continuous improvement and communicate significant issues to Quality and business leadership.

EDUCATION AND EXPERIENCE

• 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 initial risk assessment, validation planning, requirements, testing, traceability, release, change control, periodic review, incident management, data migration, and system retirement.
• Experience reviewing and approving computer system validation or assurance documentation, such as validation plans, system risk assessments, requirements specifications, test plans and evidence, requirements traceability matrices, deviations, validation summary reports, and change-control records.
• Working knowledge of applicable regulatory requirements and industry expectations, including 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, such as electronic data capture, clinical trial management, electronic trial master file, interactive response technology, laboratory information management, electronic laboratory notebook, chromatography data, quality management, and other GxP-regulated platforms.
• Experience with risk-based validation and assurance approaches for configurable commercial software, software-as-a-service solutions, 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 the assessment and remediation of computerized-system compliance observations.
• Demonstrated experience working collaboratively with system owners, Information Technology, Information Security, Clinical Operations, Laboratory Operations, Quality Assurance, vendors, and other stakeholders in a matrixed and geographically dispersed organization.
• Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.

 Preferred Education and Experience: 

• Master’s degree in life sciences, computer science, information systems, engineering, quality management, regulatory affairs, or related discipline.
• Experience working within a contract research organization, regulated laboratory, biotechnology, pharmaceutical, or medical-device organization.
• Experience providing QA oversight across multiple GxP environments, particularly GCP, GLP, GCLP, and GMP.
• Experience managing or developing a geographically dispersed or global validation and quality team.
• Experience with laboratory platforms and instrument software, including LIMS, ELN, CDS, data-acquisition systems, interfaces, and automated laboratory workflows.
• Experience with clinical platforms, including EDC, CTMS, eTMF, IRT/RTSM, eCOA/ePRO, safety databases, and related data integrations.
• Experience with Agile, Waterfall, or hybrid system-development methodologies and the application of risk-based quality controls within the system development lifecycle.
• Experience hosting or supporting health-authority inspections and sponsor audits involving computerized systems, electronic records, data integrity, or system validation.
• Relevant professional certification, such as ASQ Certified Quality Auditor, ASQ Certified Manager of Quality/Organizational Excellence, ISACA Certified Information Systems Auditor, or an equivalent quality, auditing, or computer-system validation credential.
• Familiarity with current Good Automated Manufacturing Practice guidance and risk-based computer software assurance principles.