Senior Quality Engineer, QMS

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.

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.