Software Quality Assurance Specialist III
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Job Description
Software Quality Assurance Specialist ensuring compliance with regulatory requirements in healthcare. Leading Computer System Validation efforts and collaborating with cross-functional teams for high-quality standards.
Responsibilities:
- Project Leader for Computer System Validation (CSV) programs across Jabil Healthcare, ensuring alignment with global and site-specific objectives.
- Subject Matter Expert (SME) in the validation of computerized quality systems and applications, providing strategic guidance and technical oversight.
- Lead compliance initiatives related to FDA 21 CFR Part 11 and EU Annex 11, ensuring systems meet regulatory expectations.
- Coach and mentor CSV leads/supervisors on procedures, forms, templates, and regulatory requirements, fostering a culture of compliance and continuous improvement.
- Drive the standardization of CSV processes across the site in accordance with global, regional, and site-level directives.
- Champion adherence to global regulations and standards, including ISO 13485, FDA 21 CFR Part 11, and EU Annex 11.
- Provide support during regulatory audits and inspections, ensuring readiness and robust documentation.
- Accountable for CSV metrics to the global metrics team, contributing to enterprise-wide performance tracking.
- Collaborate with cross-functional teams (QA, IT, Manufacturing, R&D) to define system requirements and validation strategies.
- Ensure all validation activities are conducted in accordance with Jabil CSV procedures and associated work instructions.
- Review and approve validation deliverables, ensuring completeness, accuracy, and compliance.
- Monitor the Master System Inventory, ensuring accurate tracking of all GxP systems.
- Monitor system performance and revalidate as necessary after upgrades or changes.
- Lead periodic reviews of GxP systems and conduct risk assessments and impact analyses for both new and existing systems.
- Ensure compliance with the company’s security policies and procedures.
- Perform additional duties and responsibilities as assigned, contributing to the overall success of the CSV program.
Requirements:
- Minimum 8 years of relevant experience in Computer System Validation, Software Quality Assurance, or related roles within a regulated (GxP) environment.
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical discipline (Master’s degree preferred).
- Deep knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ISO 13485.
- Proven experience leading CSV projects and delivering validation documentation (URS, Risk Assessments, IQ/OQ/PQ, Validation Plans/Reports).
- Strong understanding of GxP system lifecycle management, including periodic reviews, change control, and revalidation.
- Demonstrated ability to work cross-functionally with QA, IT, Manufacturing, and R&D teams.
- Experience supporting regulatory inspections (FDA, Notified Bodies, internal audits).
- Excellent communication, coaching, and stakeholder management skills.
- Strong analytical and problem-solving capabilities, with demonstrated attention to detail.
- Ability to manage multiple priorities in a fast-paced, global manufacturing environment.
Benefits:
- Health insurance
- Professional development opportunities
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