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Quality & Compliance Manager, Computer System Validation

21 hours, 10 minutes ago
United States
Full-time
Senior
Manual QA Tester
Quality Assurance and Testing
Agile
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 93

Description

  • Provide independent, risk-based QA oversight across computerized-system lifecycles from implementation through retirement.
  • Review and approve validation plans, risk assessments, requirements, traceability records, test evidence, deviations, summary reports, and release documentation.
  • Ensure systems remain fit for intended use, maintain data integrity, and comply with regulatory and internal requirements.
  • Oversee validated-state activities including changes, incidents, CAPAs, upgrades, migrations, periodic reviews, and decommissioning.
  • Support qualification and oversight of software, cloud, data, and computerized-system service providers.
  • Develop and improve CSV/CSA policies, procedures, templates, tools, and training.
  • Prepare for and support sponsor audits, regulatory inspections, and internal audits.
  • Establish validation and compliance metrics, identify emerging risks, and drive continuous improvement.

Requirements

  • Bachelor’s degree in a relevant scientific, technical, engineering, healthcare, or information-systems discipline.
  • At least 6 years of progressively responsible experience in QA, computer system validation, computer software assurance, or IT quality within regulated life sciences.
  • Demonstrated QA oversight of GxP systems across risk assessment, planning, testing, release, change control, periodic review, incidents, migration, and retirement.
  • Experience reviewing and approving validation and assurance documentation, including traceability matrices, test evidence, deviations, and summary reports.
  • Knowledge of FDA electronic records/signatures requirements, EU Annex 11, ICH GCP, GLP, and data-integrity principles.
  • Experience with CRO, clinical, laboratory, or other GxP platforms such as EDC, CTMS, eTMF, LIMS, ELN, CDS, and instrument software.
  • Experience with risk-based validation for SaaS, hosted, configurable, interfaced, laboratory, and internally developed systems.
  • Experience with supplier qualification, audits, inspections, and remediation of computerized-system compliance findings.
  • Preferred: master’s degree, global or geographically dispersed team experience, Agile/Waterfall methodologies, relevant professional certification, and familiarity with GAMP and CSA principles.
  • Must be legally authorized to work in the country of employment without employer sponsorship.

Benefits

  • Annual salary range of $91,500–$120,000 USD.
  • Eligibility for a discretionary annual bonus.
  • Health, life, and disability insurance.
  • Retirement savings benefits.
  • Parental leave.
  • Paid sick leave and vacation time.

Interested in this position?

Apply directly on the company website

Apply Now

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