Engineer - Quality - Global CSQA

Role Summary

The Engineer - Quality - Global Computer Systems Quality Assurance (CSQA) ensures that assigned functional areas, projects and/or systems comply with corporate CSV standards. Provides consultation and interpretation of Corporate Computer Systems Standards, Practices, and Procedures, oversees CSV execution, maintains awareness of relevant standards, and ensures inspection readiness within supported areas. Primarily aligned with Information Systems Quality, with a significant portfolio in Manufacturing and Quality; preference given to candidates with strength in manufacturing execution systems, laboratory information management systems, and quality systems.

Responsibilities

• Maintain Inspectional Readiness
  • Ensure supported systems are validated in compliance with applicable standards and procedures
  • Ensure all quality actions and commitments for supported areas are appropriately tracked
  • Participate in self-inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understood
  • Ensure all Inspection Readiness materials are current and appropriate
  • Provide periodic updates to key stakeholders
  • Escalate issues appropriately
• Deliver Projects, Programs, And Support
  • Provide consultation and interpretation on policies and procedures as related to the supported computer system
  • Provide training to customer areas on CSV-related topics as needed
  • Partner with Business, Business Quality, and IT customer areas to deliver business value
  • Understand customer, company, and Quality priorities
  • Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed
  • Engage customers and Quality Assurance management in appropriate discussions of risk management
  • Ensure suppliers of computer systems or services meet quality expectations
  • Escalate computer system quality issues to the appropriate persons
  • Strive for and promote consistency within the CSQA organization
• Streamline And Continuously Improve
  • Eliminate non-value-added activities to focus on continuous quality assurance improvements, including process improvement projects
  • Identify opportunities for streamlining and simplification and assist in developing improved solutions
  • Understand external trends and potential ramifications for the supported IT area(s)
• Grow Capabilities And Knowledge
  • Share lessons learned and best practices with others
  • Support teammates by sharing experience, providing backup coverage, consulting and assistance

Qualifications

• Required: Bachelor’s degree in a technology-related field such as Computer Science
• Required: 5+ years’ experience in IT, Automation, or computer system validation
• Preferred: Understanding of process development and/or improvement (e.g. Six Sigma)
• Preferred: Experience conducting risk assessments, self-inspections, audits and/or supplier assessments
• Preferred: Demonstrated ability to communicate with customers, including strong oral and written communication and presentation skills
• Preferred: Demonstrated influence and mentoring skills with peers and management
• Preferred: Proficiency with IT systems development life cycle
• Preferred: Proficiency with Microsoft Office products
• Preferred: Experience with Computer Systems Validation
• Preferred: Prior IT system development experience or QA experience
• Preferred: Competency in IT technical disciplines (e.g., Information Security, Programming, Data Analytics, Cloud)
• Preferred: Knowledge of IT Best Practices (e.g., COBIT, LSEF, ITIL, GAMP)
• Preferred: IT-control related certifications (e.g., CISA, ISO, ITIL, CSQE)

Education

• Bachelor’s degree in a technology-related field such as Computer Science

Skills

• Knowledge of computer systems validation and regulatory expectations
• Strong communication and stakeholder management
• Risk management and quality assurance collaboration across IT, Business, and Quality
• Ability to interpret and apply CSV standards, practices, and procedures
• Proficiency with IT lifecycle methodologies and related tools