Senior Quality Engineer. QMS

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Job Description:

The Senior Quality Engineer provides technical quality leadership for computerized systems, equipment, and digital solutions used within a regulated environment. This role is responsible for developing and executing Computerized System Validation (CSV) strategies, applying risk-based approaches to qualification and validation, providing quality guidance with change management, and ensuring systems and processes maintain appropriate data integrity throughout their lifecycle.

The Senior Quality Systems Engineer partners with Quality, Manufacturing, Engineering, IT, Automation, system owners, and business process owners to ensure that systems are fit for intended use, appropriately controlled, and maintained in a validated state. The position serves as a subject matter expert and provides practical, risk-based guidance that balances compliance requirements, patient/product risk, and operational needs

Key Responsibilities

• Support qualification and validation activities for equipment, systems, including computerized systems used in regulated business and manufacturing processes.
• Apply a risk-based approach to determine the appropriate scope and rigor of qualification and validation activities.
• Review and approve lifecycle documentation such as validation plans, user requirements, functional and configuration specifications, risk assessments, test protocols/scripts, traceability documentation, validation reports, and system retirement documentation.
• Provide change management direction and guidance on appropriate validation strategies based on intended use, system complexity, regulatory impact, and risk.
• Provide quality oversight for implementation, upgrades, configuration changes, integrations, migrations and retirement of computerized systems.
• Support investigation and resolution of validation discrepancies, test failures, and system-related quality issues.
• Ensure validated systems remain in a controlled state throughout their operational lifecycle.
• Facilitate and/or participate in system, process, and functional risk assessments.
• Use risk assessments to focus verification activities on functions that have the greatest potential impact on product quality, patient safety, data integrity, or regulatory compliance.
• Support qualification strategies for equipment, infrastructure, automation, and computerized systems, as applicable.
• Serve as a technical quality resource for data integrity assessments and remediation activities.
• Evaluate systems and processes for controls supporting ALCOA+ data integrity principles.
• Assess areas such as user access, roles and permissions, audit trails, electronic records, electronic signatures, data retention, backup/recovery, interfaces, and data lifecycle controls.
• Participate in periodic reviews and assessments of computerized systems to verify that systems remain fit for intended use and appropriately controlled.
• Support investigations involving suspected data-integrity issues and assist in determining appropriate corrective and preventive actions.
• Partner with system owners and IT to identify sustainable controls for data governance and system administration.

QS & Tech Leadership

• Provide subject matter expertise and guidance on validation, qualification, change control, and data integrity requirements.
• Interpret regulatory and industry expectations and translate them into practical, risk-based quality solutions.
• Coach engineers, system owners, validation personnel, and cross-functional partners on compliant validation and quality-system practices.
• Support inspection and audit readiness, including preparation of documentation and responses to questions related to computerized systems and validation.
• Participate in internal audits, regulatory inspections, and remediation activities as needed.
• Identify recurring compliance or process issues and recommend systemic improvements.
• Lead or contribute to continuous-improvement initiatives that simplify validation processes while maintaining effective quality controls.

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related technical discipline.
• Typically 5+ years of relevant experience in Quality, Validation, Engineering, Automation, IT Quality, or a related function within a regulated environment.
• Demonstrated experience with computerized system validation and/or equipment/system qualification.
• Experience performing or reviewing risk assessments and translating risk into appropriate validation or qualification activities.
• Working knowledge of change-control processes and validated lifecycles.
• Strong understanding of data-integrity principles and controls associated with electronic records, required.
• Demonstrated ability to review technical documentation critically and make independent, risk-based quality decisions.
• Strong written and verbal communication skills, including the ability to explain technical and compliance concepts to both technical and nontechnical stakeholders.
• Collaborate cross-functionally to determine and address data and reporting needs.
• Performs other Quality-related job duties as required.

Preferred Qualifications

• Experience in pharmaceutical, biopharmaceutical, medical device, or other regulated manufacturing environments.Knowledge of GxP, 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and quality risk-management concepts.Experience with risk-based computerized system assurance/validation approaches.Experience reviewing or validating configurable or commercial systems such as LIMS, MES, ERP, EDMS, LMS, laboratory systems, manufacturing systems, or quality management systems.Experience with automation, infrastructure, cloud-based/SaaS applications, system integrations, or data migration projects.Experience supporting regulatory inspections or internal/external audits.Familiarity with deviation management, CAPA, periodic review, supplier assessment, and system lifecycle management. 

Key Competencies

• Risk-Based Decision Making: Uses documented risk and scientific/technical rationale to determine the appropriate level of control.
• Technical Quality Leadership: Provides credible guidance while appropriately challenging both compliance gaps and unnecessary complexity
• .Problem Solving: Identifies root causes and develops sustainable solutions rather than relying solely on additional documentation or testing.
• Cross-Functional Collaboration: Works effectively across Quality, IT, Engineering, Manufacturing, Automation, and business functions.
• Data Integrity Mindset: Understands how system design, configuration, security, procedures, and human behavior affect the reliability of regulated data.
• Lifecycle Thinking: Considers validation and compliance from initial requirements and implementation through operation, change, periodic review, and retirement.
• Continuous Improvement: Looks for opportunities to simplify processes, leverage existing objective evidence, and focus resources on activities that meaningfully reduce risk.

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