Software Quality Assurance Specialist III

Software Quality Assurance Specialist III is responsible for ensuring that all computerized systems used in healthcare operations comply with regulatory requirements such as FDA 21 CFR Part 11 and EU Annex 11. This role is critical in maintaining data integrity, patient safety, and product quality through rigorous validation of software and systems.

Key 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.
• Drivethe standardizationof CSVprocesses acrossthe 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 supportduring regulatoryaudits 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 thecompany’s securitypolicies and procedures.
• Perform additional duties and responsibilities as assigned, contributing to the overall success of the CSV program.

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.

the standardization processes across

Champion adherence to global regulations and standards, including ISO 13485, FDA 21 CFR Part 11, and EU Annex 11.

during regulatory

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.

company’s security

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.

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.

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.