Quality & Compliance Manager, Computer System Validation

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $91.5k - $120k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Manage quality oversight and lifecycle validation of GxP computerized systems supporting CRO and laboratory operations • Provide independent, risk-based Quality Assurance oversight from initial assessment and implementation through operation, periodic review, significant change, and retirement • Review and approve validation and assurance deliverables, including risk assessments, validation plans, requirements, traceability documentation, test evidence, deviations, validation summary reports, and release-readiness documentation • Ensure systems are fit for intended use, maintain data integrity, and comply with procedures, client commitments, and regulatory requirements • Oversee validated-state activities including changes, incidents, deviations, CAPAs, upgrades, data migrations, periodic reviews, and decommissioning • Support qualification and ongoing oversight of software, cloud, data, and computerized-system service providers • Develop 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; coordinate responses to observations • Establish and report metrics for validation status, lifecycle compliance, overdue activities, deviations, CAPAs, supplier performance, and emerging risks • Drive continuous improvement and communicate significant issues to Quality and business leadership

🎯 Requirements

• Bachelor’s degree in life sciences, computer science, information systems, engineering, healthcare, or another relevant scientific or technical discipline • 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 • 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 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 • Experience with risk-based validation and assurance approaches for configurable commercial software, SaaS 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 remediation of computerized-system compliance observations • Experience collaborating with system owners, IT, Information Security, Clinical Operations, Laboratory Operations, Quality Assurance, vendors, and other stakeholders in a matrixed and geographically dispersed organization • Equivalent combination of education, professional training and experience may qualify • Preferred: Master’s degree, regulated-industry experience, GxP environment experience, team-management experience, laboratory and clinical platform experience, Agile/Waterfall/hybrid methodology experience, inspection and audit experience, relevant professional certification, and familiarity with GAMP guidance and risk-based computer software assurance principles

🏖️ Benefits

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