Software Quality Assurance Specialist III (m/f/d)
Jabil
Software Quality Assurance Specialist III (m/f/d)
Job Description
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.
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.
BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact your local police department. Any scam job listings should be reported to whatever website it was posted in.
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.
Accessibility Accommodation
If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.#whereyoubelong
Locations
- Remote - Germany, Germany (Remote)
Salary
75,000 - 95,000 EUR / yearly
Source: AI Estimation
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Computer System Validation (CSV)intermediate
- FDA 21 CFR Part 11intermediate
- EU Annex 11intermediate
- GAMP 5intermediate
- ISO 13485intermediate
- GxP system lifecycle managementintermediate
- Validation documentation (URS, Risk Assessments, IQ/OQ/PQ, Validation Plans/Reports)intermediate
- Cross-functional collaboration (QA, IT, Manufacturing, R&D)intermediate
- Regulatory inspections supportintermediate
- Communication and stakeholder managementintermediate
- Analytical and problem-solvingintermediate
- Project leadership and coachingintermediate
Required Qualifications
- Minimum 8 years of relevant experience in Computer System Validation, Software Quality Assurance, or related roles within a regulated (GxP) environment (experience)
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical discipline (Master’s degree preferred) (experience)
- Deep knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ISO 13485 (experience)
- Proven experience leading CSV projects and delivering validation documentation (URS, Risk Assessments, IQ/OQ/PQ, Validation Plans/Reports) (experience)
- Strong understanding of GxP system lifecycle management, including periodic reviews, change control, and revalidation (experience)
- Demonstrated ability to work cross-functionally with QA, IT, Manufacturing, and R&D teams (experience)
- Experience supporting regulatory inspections (FDA, Notified Bodies, internal audits) (experience)
- Excellent communication, coaching, and stakeholder management skills (experience)
- Strong analytical and problem-solving capabilities, with demonstrated attention to detail (experience)
- Ability to manage multiple priorities in a fast-paced, global manufacturing environment (experience)
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
Benefits
- general: Health insurance
- general: Paid time off
- general: Retirement plan contributions
- general: Professional development support
Tags & Categories
Answer 10 quick questions to check your fit for Software Quality Assurance Specialist III (m/f/d) @ Jabil.
Related Books and Jobs
Software Quality Assurance Specialist III (m/f/d)
Jabil
Software Quality Assurance Specialist III (m/f/d)
Job Description
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.
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.
BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact your local police department. Any scam job listings should be reported to whatever website it was posted in.
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.
Accessibility Accommodation
If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.#whereyoubelong
Locations
- Remote - Germany, Germany (Remote)
Salary
75,000 - 95,000 EUR / yearly
Source: AI Estimation
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Computer System Validation (CSV)intermediate
- FDA 21 CFR Part 11intermediate
- EU Annex 11intermediate
- GAMP 5intermediate
- ISO 13485intermediate
- GxP system lifecycle managementintermediate
- Validation documentation (URS, Risk Assessments, IQ/OQ/PQ, Validation Plans/Reports)intermediate
- Cross-functional collaboration (QA, IT, Manufacturing, R&D)intermediate
- Regulatory inspections supportintermediate
- Communication and stakeholder managementintermediate
- Analytical and problem-solvingintermediate
- Project leadership and coachingintermediate
Required Qualifications
- Minimum 8 years of relevant experience in Computer System Validation, Software Quality Assurance, or related roles within a regulated (GxP) environment (experience)
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical discipline (Master’s degree preferred) (experience)
- Deep knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ISO 13485 (experience)
- Proven experience leading CSV projects and delivering validation documentation (URS, Risk Assessments, IQ/OQ/PQ, Validation Plans/Reports) (experience)
- Strong understanding of GxP system lifecycle management, including periodic reviews, change control, and revalidation (experience)
- Demonstrated ability to work cross-functionally with QA, IT, Manufacturing, and R&D teams (experience)
- Experience supporting regulatory inspections (FDA, Notified Bodies, internal audits) (experience)
- Excellent communication, coaching, and stakeholder management skills (experience)
- Strong analytical and problem-solving capabilities, with demonstrated attention to detail (experience)
- Ability to manage multiple priorities in a fast-paced, global manufacturing environment (experience)
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
Benefits
- general: Health insurance
- general: Paid time off
- general: Retirement plan contributions
- general: Professional development support
Tags & Categories
Answer 10 quick questions to check your fit for Software Quality Assurance Specialist III (m/f/d) @ Jabil.
Related Books and Jobs