The primary responsibilities of this role, QA Validation Specialist, are to: Provide manufacturing support as a subject matter expert, delivering QA oversight for qualification and validation of manufacturing processes, facilities, utilities, equipment, and technical systems; Serve as subject matter expert for validation lifecycle requirements, 21 CFR Part 11, ICH guidelines, and risk-based qualification approaches, ensuring alignment with current regulations and industry trends; Review and approve qualification and validation documentation for systems and processes, including impact assessments, URS, risk assessments, traceability matrices, IQ, OQ, PQ, data migration activities, and related SOPs; Maintain and continuously improve the site validation program and associated procedures, including Validation Plans, Validation Master Plans, and Validation SOPs, to align local practices with corporate and regulatory expectations; Identify compliance issues, conflicting requirements, inefficiencies, or improvement opportunities in procedures and practices; lead discussions and drive remediation activities to completion; Provide QA oversight of SOPs for technical systems and operations, approve SOPs, and influence internal partners on best practices, compliant processes, and high-quality documentation; Resolve and approve validation discrepancies, participate in investigations related to validation failures, and assess changes to technical systems for validation and quality impact; Utilize in-depth knowledge of GMP quality systems to assess critical issues, understand validation impact on product quality and quality system elements, and represent the site validation program and strategy during internal and external audits; Provide project team leadership by planning and facilitating team activities, supervising contractors as needed, and partnering cross-functionally to define effective approaches to accomplishing validation-related tasks; Work independently on problems of complex scope, exercise sound judgment in selecting methods and techniques, and propose new strategies to streamline computerized system validation and related processes. This salary range is merely an estimate and may vary based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors.