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Precision Medicine GroupQuality & Compliance Manager, Computer System Validation
Precision Medicine Group seeks a Quality & Compliance Manager for Computer System Validation to direct the quality oversight and lifecycle management of GxP computerized systems supporting…
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About This Role
Precision Medicine Group seeks a Quality & Compliance Manager for Computer System Validation to direct the quality oversight and lifecycle management of GxP computerized systems supporting contract research organization and laboratory functions. This full-time, on-site role involves collaborating with information technology teams, system owners, operational staff, and external vendors to guarantee that platforms remain fit for their intended purpose, uphold data integrity, and stay inspection-ready from deployment to retirement. The…
Job Description
Precision Medicine Group seeks a Quality & Compliance Manager for Computer System Validation to direct the quality oversight and lifecycle management of GxP computerized systems supporting contract research organization and laboratory functions. This full-time, on-site role involves collaborating with information technology teams, system owners, operational staff, and external vendors to guarantee that platforms remain fit for their intended purpose, uphold data integrity, and stay inspection-ready from deployment to retirement. The practitioner will establish risk-driven computer system assurance methods and drive continuous enhancement across clinical and lab settings.
This position fits professionals who have extensive background in quality assurance and computer system validation within regulated life sciences sectors. The individual will review and authorize validation artifacts, oversee the validated state of platforms during upgrades or incidents, and prepare for regulatory inspections and sponsor evaluations. Candidates must possess legal authorization to work in the employment country without requiring employer sponsorship.
Responsibilities
- Provide independent quality assurance oversight for GxP computerized systems spanning their entire lifecycle from initial assessment to retirement
- Review and authorize validation deliverables including risk assessments, validation plans, traceability documents, testing evidence, deviations, and summary reports
- Ensure computerized systems maintain data integrity and comply with internal standards, client agreements, and regulatory rules regarding electronic records and signatures
- Oversee platforms supporting clinical research and laboratories such as clinical platforms, lab information systems, electronic notebooks, and chromatography data systems
- Manage the ongoing validated state by evaluating system modifications, incidents, corrective actions, upgrades, data migrations, and decommissioning
- Identify and escalate compliance and data integrity risks while verifying that proper remediation is completed and documented
- Support the qualification and ongoing management of software, cloud, data, and system service providers
- Develop and improve policies, standard procedures, templates, and training for computer system validation and software assurance
- Prepare for and assist with sponsor audits, regulatory inspections, and internal evaluations involving computerized systems
- Establish and report validation metrics concerning lifecycle compliance, overdue tasks, deviations, corrective actions, and supplier performance
Requirements
- Hold a Bachelor’s degree in life sciences, computer science, information systems, engineering, healthcare, or another related scientific or technical field
- Accumulate at least six years of progressively responsible experience in Quality Assurance, computer system validation, software assurance, or information technology quality within a regulated life sciences industry
- Possess legal authorization to work in the country of employment without employer sponsorship
Qualifications
- Earn a Master’s degree in life sciences, computer science, information systems, engineering, quality management, regulatory affairs, or a related discipline
- Bring previous experience working inside a contract research organization, regulated laboratory, biotechnology, pharmaceutical, or medical device enterprise
- Demonstrate background providing quality oversight across multiple GxP environments including GCP, GLP, GCLP, and GMP
- Show experience managing or developing a geographically dispersed or global validation and quality team
- Hold relevant professional credentials such as ASQ Certified Quality Auditor, ASQ Certified Manager of Quality, or ISACA Certified Information Systems Auditor
Core Skills
Benefits
- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance and disability benefits
- Parental leave
- Paid time off for sick leave and vacation
Frequently Asked Questions
What is the employment type for this position?
This is a full-time position.
Is this a remote role?
No, this is an on-site role.
What is the salary range for this role?
The reasonable estimate of the current salary range is $91,500 to $120,000 USD, depending on factors such as skills, experience, and training.
Are visa sponsorship services provided?
No, candidates must be legally authorized to work in the country of employment without employer sponsorship.
What location is this position based in?
The exact location is not specified in the posting beyond being an on-site position.
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