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What Computer System Validation Quality Assurance (CSV QA) contributes to Cardinal Health (CAH)

Information Technology oversees the effective development, delivery, and operation of computing and information services. This function supports the implementation, maintenance, and retirement of regulated computerized systems.   

The CSV QA provides support, consultation, and documentation review on QSR-GxP software validation projects and deliverables to ensure the proper development and validation of computer systems to meet all internal, corporate and external regulatory requirements, including supplier assessment and system periodic reviews.

BASIC FUNCTIONS:  

As a key leader within the CSV Quality Assurance organization, the Software Quality Assurance engineer will:

• Support the Software Quality Assurance (SQA) organization in supplier audit, periodic review, training, and control activities.
• Provide oversight for our processes and technologies supporting regulatory compliance for non-product software and serve as process owner for software validation.
• Serve as a key stakeholder in CSV compliance toward the business and engineering communities and represent the Quality and Regulatory function to IT, customers, clients, and regulatory agencies as appropriate.
• Advocate for change in achieving compliance across both technology and business teams.
• Function as the Quality owner and as a subject matter expert for our software validation practice and process for applicable systems.

SPECIFIC RESPONSIBILITIES AND ACCOUNTABILITIES:

• Support the CSV Quality Assurance (CSV QA) program to integrate software validation practice with standard CAH development tools and outputs.
• Function as a key advocate and ambassador for the quality and engineering communities towards compliance through automation adoption
• Understand and maintain knowledge of CSV Quality Assurance technology and industry trends.
• Develop metrics to measure successful transformational outcomes or areas of focus.
• Challenge the status quo and operational barriers that impede our compliance transformation.
• Evangelize the mission of CSV QA through identification and communication of success stories and outcomes.
• Defend CAH software validation practice and validated technology solutions to our customer, clients, and stakeholders.
• Responsible for execution of Computer Systems Periodic Reviews.
• Provides support, consultation, and documentation review on QSR-GxP software validation projects and deliverables to ensure the proper development and validation of computer systems to meet all internal, corporate and external regulatory requirements.
• Provides support to all internal, corporate and external Regulatory Audits as they pertain to Computer Systems Validation/Compliance efforts.
• Assists in the development of CSV Training Materials and conducts CSV Training as needed. 
• Manages and/or conducts Software Supplier Audits and their follow up.
• Monitors and ensures closure of any corrective actions that are assigned to SQA.
• Supports maintenance of CSV QA System Inventory.

QUALIFICATIONS

• Bachelor's degree in related field or 5+ years of experience in related field.
• Understanding and execution of non-product Computer System Validation practices and processes in the life science industry, including validation of SaaS, IaaS, PaaS.
• Experience in Supplier assessment for custom or commercial off the shelf non-product software, periodic review for validated systems and defending the practice and outcomes of software validation.
• Working knowledge and experience in Good clinical, laboratory, manufacturing, and distribution Practice (GxP) and QSR Regulations
• Experience and knowledge of GAMP, AAMI or other practice frameworks
• Strong interpersonal and communication skills and proven ability to work effectively with all organizational levels.
• Ability to influence change across leadership, team members and key stakeholders through relationship building and collaboration.
• Strong collaboration, facilitation, and conflict management skills.
• Strong problem-solving skills - effective at developing creative solutions and removing barriers.

EXPECTATIONS OF ROLE LEVEL:

• Contributes to the development of policies and procedures to achieve specific goals.
• Interacts with peer customers and suppliers at various management levels and may interact with senior management.
• Interactions normally involves resolution of issues related to operations and/or projects.
• Gains consensus from various parties involved.
• Asks thoughtful questions.
• Respectfully challenges existing processes and assumptions and is willing to modify their own thinking based on findings.
• Comes to group discussions with new ideas, diverse perspectives and solutions that can help move forward, rather than focusing on problems and limitations.
• Starts discussions with confirming common or competing priorities and goals.
• Maintains focus on broader priorities throughout conversations.
• Looks beyond data to understand implications for those outside their own team.

OTHER SKILLS:

• Certification by ASQ in Software Quality Engineering (CSQE) or similar
• Certification by ASQ in Quality Auditing (CQA) or similar

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.