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Salary: USD 91,500 - 120,000 / annual
Precision Medicine Group seeks a Quality & Compliance Manager for Computer System Validation to oversee the quality assurance and lifecycle validation of GxP computerized systems supporting CRO and laboratory operations. This role is critical to ensuring systems remain fit for intended use, maintain data integrity, and stay compliant and inspection-ready from implementation through retirement.
Key Responsibilities:
- Provide independent, risk-based QA oversight of GxP computerized systems throughout their lifecycle, including initial assessment, implementation, operation, periodic review, significant change, and retirement.
- Review and approve validation and assurance deliverables such as system risk assessments, validation plans, requirements, traceability documentation, test evidence, deviations, and validation summary reports.
- Ensure computerized systems comply with internal procedures, client commitments, and regulatory requirements, including electronic records, electronic signatures, audit trails, access controls, security, backup, archival, and record retention.
- Provide QA oversight for systems supporting clinical research and laboratory activities, including clinical platforms, laboratory information systems, electronic laboratory notebooks, chromatography data systems, instrument software, interfaces, and automated workflows.
- Oversee the ongoing validated state of systems by evaluating changes, incidents, deviations, corrective and preventive actions, upgrades, data migrations, periodic reviews, and decommissioning activities.
- Support qualification and ongoing oversight of software, cloud, data, and computerized-system service providers, partnering with Quality, IT, Information Security, Clinical Operations, Laboratory Operations, system owners, and vendors.
- Develop, maintain, and improve policies, procedures, templates, tools, and training for computer system validation and software assurance 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, and inspection-ready.
- Establish and report meaningful metrics for validation status, lifecycle compliance, overdue activities, deviations, CAPAs, supplier performance, and emerging risks to drive continuous improvement.
Requirements:
- Bachelor's degree in life sciences, computer science, information systems, engineering, healthcare, or another relevant scientific or technical discipline.
- Minimum 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.
Preferred Qualifications:
- 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.
