• Led strategic initiatives for new product introductions and lifecycle management, ensuring compliance with cGMPs, ICH guidelines, and global regulations.• Directed all phases of equipment, computerized systems, and method lifecycle management, from acquisition and commissioning to validation, optimization, tech transfer, periodic review, and decommissioning.• Led the technical review of analytical data, ensuring data integrity and guided the technical content of protocols and reports.• Orchestrated a robust global supply center stability program with comprehensive oversight of the global reference standards and controls/critical reagents. • Spearheaded the development and standardization of technology transfer and validation procedures in collaboration with global functions and operations and clinical QA, ensuring streamlined processes and adherence to best practices.• Collaborated with global teams to successfully drive method development, optimization, transfer and troubleshooting initiatives.• Led performance management efforts for the QC Technical Services department, aligning with strategic objectives and driving productivity, accountability, and professional growth among team members.• Successfully managed department contracts and agreements with external contract organizations.• Produced QC deliverables for Quality Management Reviews (QMR) and Annual Product Reviews (APR).• Managed the drafting, review, and approval of CMC sections for US and international regulatory applications, responses to regulatory inquiries, supplemental biologics license applications, and international variations pertaining to QC operations.• Successfully managed QC-related audit activities and hosted internal inspections. Effectively presented validations and stability programs to regulatory authorities during inspections, ensuring adherence to compliance standards. Proactively managed timely responses and closure of action items to maintain regulatory compliance.

• Established qualification and validation standards that align with global regulations, regulatory trends, and Bayer's quality requirements.• Managed site-wide controlled temperature environments (CTEs) and sterilization systems in strict accordance with established standards. Oversaw validation of computerized systems owned by Quality Validation.• Developed and managed supply center Validation Lifecycle documentation, encompassing Validation Master Plans, Validation Plans, Validation Status Lists, and SOPs.• Established and lead the site Validation Program Board, ensuring alignment of qualification and validation requirements across the site in strict accordance with regulatory standards.• Led technical assessment activities for site change control, ensuring effective evaluation and implementation of technical changes in compliance with regulatory requirements.

• Managed site-wide equipment requalification and thermal mapping for controlled temperature environments (CTEs), sterilizers, lyophilizes, and SIP systems. Oversaw validation of computerized systems owned by Quality Validation.

• Conducted QA review of qualification and validation protocols, reports, change controls, and SOPs, ensuring compliance and accuracy.• Directed an equipment requalification program, overseeing scheduling, protocol generation, execution, test result analysis, report preparation, and management of junior personnel and contractors.• Performed process validation for bulking, aseptic processing, lyophilization, capping, and packaging encompassing study design and execution.

• Performed process validation and requalification for bulking, aseptic processing, lyophilization, capping, and packaging encompassing study design and execution.

• Maintained an existing building water distribution system.• Qualified a new building water distribution system.• Investigated discrepancies associated with water systems, clean steam, cold rooms, and equipment.• Initiated Change Control related to maintenance and improvements associated with facilities, utilities, and equipment. Supervised contractors performing maintenance activities.

• Participated in qualification of the new facility water distribution and clean steam systems encompassing sample collection and analysis. Performed tests, including environmental monitoring, wet chemistry, conductivity, pH, bioburden, endotoxin and Total Organic Carbon (TOC).• Maintained and validated TOC equipment. Trained personnel on operation of TOC equipment and supervised TOC testing activities.• Statistically analyzed environmental monitoring data to define alert and action limits. Recommended testing sites for environmental monitoring to ensure compliance with federal regulations.