[Hiring] Quality & Compliance Manager @Precision Medicine Group

Role Description

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.

• 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.
• Ensure computerized systems are fit for intended use, maintain data integrity, and comply with applicable internal procedures, client commitments, and regulatory requirements.
• Provide QA oversight for computerized systems supporting clinical research and laboratory activities.
• 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.
• Support the qualification and ongoing oversight of software, cloud, data, and computerized-system service providers.
• Develop, maintain, and improve policies, procedures, templates, tools, and training for computer system validation and computer software assurance.
• Prepare for and support sponsor audits, regulatory inspections, and internal audits involving computerized systems.
• Establish and report meaningful metrics for validation status, lifecycle compliance, overdue activities, deviations, CAPAs, supplier performance, and emerging risks.

Qualifications

• 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.
• Experience reviewing and approving computer system validation or assurance documentation.
• Working knowledge of applicable regulatory requirements and industry expectations.
• Experience supporting computerized systems used in CRO, clinical research, or laboratory operations.
• Experience with risk-based validation and assurance approaches for configurable commercial software.
• 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 various stakeholders in a matrixed and geographically dispersed organization.
• Or equivalent combination of education, professional training and experience.

Requirements

• Master’s degree in life sciences, computer science, information systems, engineering, quality management, regulatory affairs, or related discipline (preferred).
• Experience working within a contract research organization, regulated laboratory, biotechnology, pharmaceutical, or medical-device organization (preferred).
• Experience providing QA oversight across multiple GxP environments (preferred).
• Experience managing or developing a geographically dispersed or global validation and quality team (preferred).
• Experience with laboratory platforms and instrument software (preferred).
• Experience with clinical platforms (preferred).
• Experience with Agile, Waterfall, or hybrid system-development methodologies (preferred).
• Experience hosting or supporting health-authority inspections and sponsor audits (preferred).
• Relevant professional certification (preferred).
• Familiarity with current Good Automated Manufacturing Practice guidance and risk-based computer software assurance principles (preferred).

Benefits

• Discretionary annual bonus.
• Health insurance.
• Retirement savings benefits.
• Life insurance and disability benefits.
• Parental leave.
• Paid time off for sick leave and vacation.