Senior Quality Engineer I- Global Quality Systems & Processes

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We are seeking an experienced Quality Engineering (QE) professional to joinKitesGlobal Quality Systems & Complianceteam. The ideal candidate thrives in a collaborative environment that embraces continuous improvement innovation and riskbased decisionmaking. This individual will work crossfunctionallydemonstratestrong initiative and communicate effectively at all organizational levels.

General responsibilities include providing quality oversight of enterprise systems related to Computer System Validation (CSV) ensuring compliance with internal procedures global regulatory requirements and industry standards. This position promotes Quality by Design principles by leading and/orparticipatingin validation activities risk assessments system lifecycle management and supporting Quality Management System (QMS) processes.

Responsibilities

• Provide quality oversight for enterprise crossfunctional and sitelevel computer system validation activities ensuring alignment with GMP 21 CFR Part 11 Annex 11 Data Integrity principles and applicable industry guidance.

• Support and apply a riskbased approach to the qualification validation and lifecycle management of enterprise.

• Ensure GMPrelevant computer systemscomply withregulations internal procedures and industry best practices.

• Review and assess proposed changes tovalidatedsystems determiningappropriate levelsof validation testing and documentation.

• Review technical documentation workflow diagrams test requirements and resource needs to support validation and changecontrol activities.

• Review and approve validation deliverablesincluding Validation Plans Qualification Protocols UAT Plans and Test Cases Traceability Matrices and Validation Summary Reportsto ensure compliance and quality standards.

• Drive innovation and process optimization related to validation and testing approaches including adoption of automation streamlined testing strategies and Computer Software Assurance (CSA) principles.

• Support implementation validation and integration of Manufacturing Automation Systems and their interoperability with enterprise platforms.

• Serve as the validation representative on project teams providing cGMP and CSVexpertiseduring system design implementation configuration and lifecycle activities.

• Providequality oversight and support for new system introductions upgrades enhancements and system retirement activities.

• Act as Quality Reviewer/Approver forvalidationactivities within the QMS.

• Provide quality oversight during change control execution to ensureaccuratetechnical impact assessments proper documentation and validated state maintenance.

• Support internal and external audits regulatory inspections and inspectionreadiness activities.

• Drive continuous improvement initiatives related to CSV data integrity system lifecycle management and QMS processes.

• Support Data Integrity governance activities including ALCOA compliance DI risk assessments periodic reviews and systemlevel controls.

• Participate in system lifecycle activities such as periodic reviews access reviews backup/restore testing disaster recovery validation and retirement planning.

• Support supplier qualification activities forGxPrelevant cloud SaaS or vendormanaged systems including participation in vendor audits.

• Collaborate with IT Security to ensureappropriate cybersecuritycontrols forGxPsystems (e.g. identity management audit trails vulnerability assessments).

• Contribute to development review and improvement of procedures work instructions templates and training related to CSV data integrity andGxPsystem governance.

• Partner with IT and business owners to support service levels incident management deviation handling and problem resolution in alignment with ITIL principles.

• Communicate effectively with functional teams leadership and global partners to ensure alignment transparency and collaborative problemsolving.

• Perform other duties as assigned.

Basic Qualifications

• Masters degree and 4 years of Computer Systems experience
  OR

• Bachelors degree and 6 years of Computer Systems experience
  OR

• Associate degree and 8 years of Computer Systems experience
  OR

• High School Diploma/GED and 10 years of Computer Systems experience

Preferred Qualifications

• Experience in software quality assurance or quality oversight roleswithin a biopharmaceutical environment

• 5 years in an FDAregulated environment withstrongunderstanding ofcGxPstandards and riskbased validation principles.

• Demonstrated ability to review validation documentation lifecycle deliverables deviations and nonconformances.

• Strong critical thinking troubleshooting and problemsolving skills.

• Selfmotivated and adaptable with willingness to take on responsibilities beyondinitialjob scope.

• Prior experience withenterprise systems (e.g. ERP LIMS MES QMS).

• Excellent interpersonal verbal and written communication skills.

• Comfortable working in a fastpaced and dynamic environment.