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

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👻 Ghost score 12%

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Provide independent, risk-based Quality Assurance oversight of GxP computerized systems throughout the system lifecycle • 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 computerized systems are fit for intended use, maintain data integrity, and comply with procedures, client commitments, and regulatory requirements • Provide QA oversight for clinical and laboratory computerized systems, including clinical platforms, laboratory information systems, electronic laboratory notebooks, chromatography data systems, instrument software, interfaces, automated workflows, and data repositories • Oversee the ongoing validated state by evaluating changes, incidents, deviations, CAPAs, upgrades, data migrations, periodic reviews, and decommissioning • Identify and escalate compliance or data-integrity risks and verify remediation • Support 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 • 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 • Establish and report 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

🎯 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 working collaboratively 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 provide the required knowledge, skills, and abilities

🏖️ Benefits

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