Remote opportunity at
pfm medical, inc.Quality & Compliance Manager, Computer System Validation
pfm medical, inc. is seeking a Quality & Compliance Manager, Computer System Validation to direct quality oversight and oversee the lifecycle validation of GxP computerized systems…
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About This Role
pfm medical, inc. is seeking a Quality & Compliance Manager, Computer System Validation to direct quality oversight and oversee the lifecycle validation of GxP computerized systems supporting contract research organization and laboratory functions. This position suits an experienced quality professional capable of collaborating with information technology, system owners, and outside providers to guarantee that platforms remain fit for intended use, uphold data integrity, and stay inspection-ready from deployment to retirement.…
Job Description
pfm medical, inc. is seeking a Quality & Compliance Manager, Computer System Validation to direct quality oversight and oversee the lifecycle validation of GxP computerized systems supporting contract research organization and laboratory functions. This position suits an experienced quality professional capable of collaborating with information technology, system owners, and outside providers to guarantee that platforms remain fit for intended use, uphold data integrity, and stay inspection-ready from deployment to retirement. The incumbent will establish risk-based computer software assurance methods, review validation documentation, monitor software changes and incidents, and promote scalability across clinical and laboratory environments. Additionally, the role involves preparing for regulatory inspections, supporting sponsor audits, and reporting metrics related to validation status and lifecycle compliance.
Responsibilities
- Provide risk-based quality assurance oversight for GxP computerized systems through all lifecycle phases
- Review and approve validation and assurance documentation including risk assessments, test evidence, and validation summary reports
- Confirm that computerized systems maintain data integrity and comply with regulatory requirements for electronic records and signatures
- Monitor ongoing system validity by evaluating changes, deviations, upgrades, and retirement activities
- Identify and escalate data-integrity risks while verifying that remediation is completed and documented
- Partner with internal departments and vendors to establish clear accountabilities and maintain proper system controls
- Develop and improve policies, procedures, and training for computer system validation and assurance
- Support sponsor audits, regulatory inspections, and internal evaluations involving computerized platforms
- Track and report metrics concerning validation status, lifecycle compliance, and open deviations
Requirements
- At least six years of progressively responsible experience in quality assurance, computer system validation, IT quality, or a related regulated life sciences discipline
- Demonstrated background in providing independent quality assurance oversight for GxP computerized systems throughout their lifecycles
- Experience reviewing and approving validation deliverables such as validation plans, risk assessments, and traceability matrices
- Working knowledge of regulatory standards including FDA electronic record requirements, EU Annex 11, ICH Good Clinical Practice, and Good Laboratory Practice
- Familiarity with systems used in clinical research, contract research organizations, or laboratories
- Legal authorization to work in the country of employment without employer sponsorship
Qualifications
- Bachelor's degree in life sciences, computer science, information systems, engineering, healthcare, or another scientific discipline
- Master's degree in life sciences, computer science, information systems, engineering, quality management, or regulatory affairs
- Background working within a contract research organization, regulated laboratory, biotechnology, pharmaceutical, or medical device organization
- Experience providing quality oversight across multiple GxP environments such as GCP, GLP, GCLP, and GMP
- Prior experience managing or developing a geographically dispersed or global validation and quality team
- Relevant professional certifications including 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 salary range for this position?
The reasonable estimate for the current salary range is between $91,500 and $120,000 USD.
What is the remote status of this job?
The posting indicates that the position is on-site.
What type of employment is this?
The posting specifies that this is a full-time employment opportunity.
Where is the job located?
The specific location of the job is not stated in the source posting.
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