Quality & Compliance Manager, Computer System Validation

pfm; United States; In loco; USD 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

pfm is seeking a Quality & Compliance Manager, Computer System Validation to lead QA oversight of GxP systems across their lifecycle in CRO and laboratory environments.

Responsibilities include reviewing validation deliverables, ensuring data integrity, and maintaining audit readiness while driving continuous improvement and risk-based practices.

Competenze

• Bachelor's degree or higher in life sciences or related field.
• Progressively responsible QA/validation experience in regulated life sciences environments.
• Experience providing independent QA oversight of GxP systems across their lifecycle.
• Familiarity with FDA/EU regulatory expectations and data integrity principles.

Mansioni

• Provide independent QA oversight of GxP computerized systems throughout their lifecycle.
• Review and approve validation and assurance deliverables like risk assessments and validation plans.
• Ensure compliance with electronic records, signatures, audit trails, access control, and data retention.
• Oversee systems supporting CRO, clinical research, and laboratory operations.
• Develop and maintain policies, procedures, and training for computer system validation.

Conoscenze

Quality Assurance

Risk assessment

Data integrity

Regulatory compliance

Formazione

Bachelor's degree in life sciences or related

Descrizione del lavoro

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 elevate 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 respons